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Investigator Site File

What is an Investigator Site File (ISF)?

ISF plays a critical role in a study’s success. The investigator site file consists of trial documents from the initiation to closeout. Maintaining the site file is the responsibility of principal investigators. Principal investigators are doctors or any medical practitioner for a particular disease or indication. Principal Investigators have many responsibilities. They conduct clinical trials under investigation. They verify informed consent and protect the rights and welfare of the patients according to applicable regulations. Importantly, investigators are responsible for preserving all data relating to a study before, during, and after the clinical trials. If documentation and filing are not followed as per ICH GCP and GDP (good documentation practice), it can lead to 483, FDA warning letters, disqualifications or restrictions, and, in extreme cases, even criminal prosecutions. This is why an Investigator site file is critical – but can also be so daunting (CRC knows!!!!). For easy understanding, we are dividing clinical trials into the phases – Before the clinical trial, During the trial, and after the trial. Before the Clinical Trial Before the trial starts i.e trial initiation, the following documentation must be filed: During the Clinical Trial As the trial progresses for the recruitment, the following documentation should be added to the files : After the Clinical Trial At the end of the trial, the final documentation must be added to the file: Conclusion Handling of documents is a critical role. The designated person and investigator have to understand the criticality of each document. This is, needless to say, a lot to keep track of. There are a lot of versions that happen when the trial continues for the years. Considering the bulk of papers and handling of documents, it is difficult to pace and track everything. In conclusion, the site should focus on an approach for the tracking of documents. Using eSIF is highly recommended.

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What is a Trial Master File?

Case Report Form (CRF)

Conducting clinical trials is a complex and time-consuming affair. It involves numerous different procedures and requires the collection of data from thousands of participants and constant monitoring. Let’s learn about CRF. A primary step towards conducting any clinical trial is to collect medical data or any other relevant data from different patients participating in the trial. The patients can be different concerning indication, and demography and may have a variety of different symptoms. Case Report Form (CRF) A Case Report Form (CRF) contains data obtained during the patient’s participation in the clinical trial. Medical researchers rely on the Case Reporting Form (CRF) to collect data about the disease from different affected patients and analyze them. CRFs can be a simple set of 1-5 questions or a detailed form with many pages. Traditionally CRFs are made of paper. Recently, researchers have adopted information technology (IT) and use electronic Case Report Form (eCRF). Electronic Case Report Form (eCRF) The electronic capture of patient data related to a clinical trial is facilitated by an electronic Case Report Form (eCRF). This method of information gathering replaces the paper-based systems previously used by clinical trial investigators to record and submit data related to the research and outcomes of a study. The switch to paperless information gathering has improved and streamlined the clinical trial data collection process in many ways. The success of a clinical trial depends on data received at the end of the trial. Data collection faces many challenges. For instance, often, a clinical trial spans several locations with the monitoring and integration of data being done from a single central location. At the same time, each trial normally comprises of hundreds of different pieces of data to be compiled and processed for statistical analysis. By providing a single portal and database to input and analyze data, clinical trial investigators and managers have a single source to turn to for highly organized and standardized information that can be quickly analyzed, sorted, and exported for the clinical trial’s progress. This automated generation and reporting are called an Electronic case report.  eCRF is greatly beneficial and has the following benefits: Electronic Case Reporting (eCRF) will automate public health case reporting by automatically generating and transmitting case reports from Electronic Health Records (EHRs) to public health agencies for further investigation, rather than manually reporting. The eCRF captures critical clinical, demographic, and laboratory reports of patient data submitted to public health. Many IT service provider companies are linked with public health agencies that develop the necessary software required to generate eCRF as per the requirements of the researchers for further study. Here is a list of 21 widely used Electronic reporting and data capture tools in the market and the companies that develop them: As the industry transitions toward electronic reporting, health information management professionals play a key role in supporting requirements for eCRF. It comes as no surprise that the manual approach of individually faxing, emailing, and making phone calls to public health agencies is time-consuming, error-prone, and inefficient, which reduces an epidemiologist’s ability to investigate potential cases promptly. 

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Clinical Data Management: Basics for Freshers

This article is posted from Clinical data management (CDM) is one of the most popular fields in clinical research. Many of the freshers and even experienced want to pursue clinical data management jobs. In the article on how to start a career in clinical data management, we discussed the groundwork and planning needed to start a career in CDM. Going forward, I will share the clinical data management basics to advanced CDM. This article will give you a free Clinical data management course. Before you read further, I recommend you to read about the history of clinical trials. Insights Let’s think, you are pursuing a PhD in Molecular pharmacology and your area of interest is breast cancer. During your research, you found a biomarker that can be used to target programmed T-cells to produce tumor-specific antibodies and also to enhance anti-tumor immunity. This will prevent healthy cells from killing and can prevent any specific drug-regulated adverse reactions. So you got results on this approach and want to pursue it further because the research shouldn’t die in labs. Every researcher’s dream is to bring his research or the molecule he identified to the market and serve his purpose. The research you did is on animals and we call this method of research “Pre-Clinical Trials”. The data generated alone during the Pre-clinical is not sufficient to release your drug into the market. you have to perform human trials on the same approach. So you go to the sponsor with the animal data that is supporting your approach has a great impact on balancing the safety-to-efficacy ratios and if the sponsor agrees, he files for the Investigational new drug application (IND). Once it is approved by the regulatory authority, the journey of clinical trials begins. Now you are skeptical of how the CDM basics and research are aligned? The role of CDM starts from the start of a clinical trial. Not only CDM, but even every field of clinical research also starts from the day the clinical trial is approved. To explain in-depth, I will give you an example of how different stakeholders in clinical trials are involved. Example: After you identified the biomarker and decided to go further ahead of pre-clinical trials, you should start by applying for IND. The process of the IND application or any regulatory requirements is handed by Regulatory writing. Adverse events and adverse drug reactions that are triggered from Phase I, till post-marketing surveillance are handled by Pharmacovigilance. The handling of data during the clinical trials is handled by Clinical data management (CDM), the writing of clinical study reports is handled by a medical writer, and the writing related to publications, representing your drug information in conferences, etc will be handled by scientific writers and we also have clinical operations which include TMF experts, CRA’s, Investigators, site coordinators, etc. These said stakeholders should work hand in hand to drive a clinical trial from its initiation to its completion, to drive a molecule from its birth to its release into the international markets. All these people should coordinate for the birth of every drug and to stand for purpose in treating patients, in giving them a better life. Every person who is working in a clinical trial is serving the purpose of every patient directly or indirectly. We are making a difference in their lives. We should feel proud to be part of clinical research. Basics of Clinical Data Management (CDM) Introduction to Clinical Data Management (CDM) Let’s get back to the molecule you found during your research that can cure breast cancer. You applied for IND and you got the approval and now you can start with the Phase 1 Clinical trial. Before you go ahead, you should have the protocol ready. So what is protocol in a clinical trial? As per the University of California, Clinical trial Protocol is defined as follows: THE PROTOCOL IS A DOCUMENT THAT DESCRIBES HOW A CLINICAL TRIAL WILL BE CONDUCTED (THE OBJECTIVE(S), DESIGN, METHODOLOGY, STATISTICAL CONSIDERATIONS, AND ORGANIZATION OF A CLINICAL TRIAL,) AND ENSURES THE SAFETY OF THE TRIAL SUBJECTS AND INTEGRITY OF THE DATA COLLECTED. Once you have the clinical trial protocol is ready, it has to be approved by the Institutional Review boards (IRBs). The clinical trial protocol and procedures are tailored to fit generic IRB submission requirements. Every site or in a generic term clinical institution or a hospital where the clinical trial is performed will have their local IRB. So the protocol is submitted to the local IRBs and once it is approved, the sites can start recruiting the subjects for the clinical trial. Once the protocol is approved, the process of Clinical data management comes into force. So what do clinical data managers or clinical data associates do after the protocols are approved? I will give a simple example. Just think you got a fever and you got to a hospital to get diagnosed and then treated right? In clinical research terms, We call the patient “Subjects“, hospitals as “Clinical Sites“, doctors “Investigators“, Nurses or other staff “Site coordinators” and the person who oversees multiple sites and checks if all the clinical sites are working as per “Good Clinical Practices”, we call as “Clinical Research Associate or CRA“. Try to remember these terms as I will be using them frequently going forward. Going back to the above example, when you go to a doctor for a fever. The doctor will check your vitals, and temperature and write it down in a case file. Also recommends you go to a lab and get the blood tested so that it will be easy for him to diagnose the problem. Once the lab results are generated, you take back those results to the doctor. He will check the results and prescribe the medications with a certain dosage regimen. If you see the whole process, there is some data generated. Just assume the amount of data that is generated in one clinical trial that will recruit around 6000-10000 patients for an average period of 10 years. The data

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Behavioral Interview Questions and Sample Answers

Behavioral interview questions are a type of interview question that asks the candidate to provide specific examples of how they have handled certain situations in the past. These types of questions are designed to help the interviewer understand how the candidate thinks, reacts, and behaves in different situations, and how they would handle similar situations in the future. Examples of behavioral interview questions include: “Can you give an example of a time when you had to handle a difficult customer?”, and “Can you tell me about a time when you had to work with a team to solve a problem?”, and “Can you describe a situation in which you had to make a difficult decision?” Please note, that the answer structures are for your reference only. Behavioral answers depend on the situation given to you. These might not be identical to the situation. Describe a situation in which you had to use conflict-resolution skills. I once had a conflict resolution situation with a colleague at work where we had different opinions about a project we were working on that we couldn’t agree on. After much discussion and heated debates, I was able to find a solution that satisfied both our needs and interests. I used active listening, open dialogue, and understanding to come to a compromise that we could both be happy with. Taking the time to find out our commonalities and having the willingness to respect each and everyone’s opinions allowed us to come to an agreement that worked for us both. How do you maintain a positive attitude when faced with an obstacle or challenge? I like to focus on the positive and think of creative solutions. When faced with an obstacle or challenge, I try to stay calm and think things through logically and objectively. I remind myself that every challenge is an opportunity to grow and strengthen my skills and resilience. Additionally, I try to look at the bigger picture and remember that the situation is not permanent and I will bounce back. Share a difficult customer service situation you faced and how you handled it. I recently faced a difficult customer service situation when a customer called our office with an urgent problem. The customer had purchased a service from our company but was dissatisfied with the results. As the customer service rep for this situation, I had to manage an already frustrated customer. I calmly explained to the customer and offered a few suggestions to help rectify the issue. I then apologized for the inconvenience they experienced and reassured them of our commitment to customer satisfaction. I also offered to expedite the process to ensure the customer got the outcome they desired. Ultimately, the customer was happy with the resolution and reassured of our commitment to customer service. Tell me about a time when you had to work with a team to achieve a goal. At my last job, I had to work with a team of fifteen people to launch a new product in the international market. It was challenging but gratifying. We all connected online and took part in regular team meetings to discuss the project’s progress and come up with ideas. We also had daily briefings to ensure everyone was updated on their individual tasks. Everyone took ownership of the project and worked hard together. In the end, the product successfully launched in time and was well-received by our customers. It was an amazing experience to see a project that started with a collective effort end with success. What do you do when you have to manage multiple projects at once? Tell me about a time when you had to disagree with a coworker over a project. When I was working on a project for _______________, I had to disagree with a coworker ____________of the project. We were both passionate about the project but had very different ideas about how to approach it. After some back and forth, I respectfully asked to put all of our ideas on the table and go through them one by one. We ended up revising our original plans and using a combination of both of our ideas, which turned out to be successful. In the end, my coworker specifically thanked me for putting all the ideas on the table and sticking to what I believed was best for the project. What do you do when your ideas are challenged by someone else? When my ideas are challenged by someone else, the first thing I do is take a step back and listen to the other person’s perspective. I try to remain respectful and open-minded and take into consideration any additional information or points of view they may have. I also ask questions to clarify any misunderstandings, in order to come to a mutual agreement or understanding between both of us. Describe a time when you had to stay calm under pressure. I was working at __________r and I received a call from ___________. He was panicking and sounding frantic because _____________. As the first responder, I had to stay calm and composed. I immediately started to assess the situation, asked specific questions, and reassured the that I was there to help. I quickly gathered his information. My composure and ability to remain calm under pressure enabled to complete the task. Share a situation when you had to be creative in achieving a goal. When I was working as an _____________for a large company, I helped organize a _______________. I had to come up with a creative way to _____________. My solution was to introduce a points-based reward system. This creative solution was a success and ultimately led to increased ______________. Tell me about a difficult decision you had to make and how you handled it. A couple of years ago, I had to decide whether I should stay at my current job or take a job offer from a different company. This was a difficult decision to make because taking the other job would

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The Ultimate Guide to Preparing for a Clinical Research Associate (CRA) Interview

Introduction The role of a Clinical Research Associate (CRA) is pivotal in the landscape of clinical trials and research. As a bridge between pharmaceutical companies and clinical trial sites, CRAs ensure the smooth execution of trials, adherence to regulatory standards, and integrity of data collected. As the industry evolves, the role of a CRA continues to become more dynamic and challenging. In this blog, we’ll delve into how you can prepare for a CRA interview, including insights into site visits, real case scenarios, challenges faced at sites, and the future outlook of the CRA role. Understanding the Role of a CRA Before heading into an interview, it’s crucial to have a deep understanding of what the role entails. A CRA is responsible for monitoring clinical trials, ensuring that they are conducted, recorded, and reported by the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Preparing for the Interview Research and Background Knowledge Common Interview Questions Real Case Scenarios and Studies Discussing real case studies can demonstrate your practical experience and problem-solving skills. Here are a few scenarios you might encounter: Site Visits Site visits are a core part of a CRA’s role. Discuss your experience with: Challenges Faced by CRAs Being a CRA is not without its challenges. In your interview, be prepared to discuss common issues such as: The Future of the CRA Role The CRA role is evolving with technological advancements and a changing clinical trial landscape. Discuss your views on: Navigating the Interview Process for Senior Clinical Research Associates: Expert Answers for Success Question 1: Can you describe your experience in clinical trial management?Answer: “In my previous roles, I’ve managed various aspects of clinical trials, including site selection, initiation, monitoring, and close-out activities. My focus has always been on ensuring compliance with study protocols and regulations. For example, in one project, I led a team through a complex multi-site trial, ensuring adherence to GCP guidelines throughout the trial’s lifecycle.” Question 2: What strategies do you use for effective site selection and initiation visits?Answer: “Effective site selection involves thorough research and feasibility assessments. I prioritize sites with a track record of adherence to trial protocols and timelines. During initiation visits, my approach includes detailed discussions with site staff to ensure they understand the study requirements, along with a comprehensive review of the infrastructure and resources available.” Question 3: How do you manage study timelines and budgets?Answer: “I manage study timelines by developing a detailed project plan and closely monitoring the progress against it. For budget management, I keep a stringent check on expenses and forecast future costs, which helps in avoiding overruns. In one of my projects, I successfully navigated unforeseen challenges by reallocating resources without impacting the overall budget.” Question 4: How do you lead and train junior CRA team members?Answer: “Leadership for me is about setting a clear example and being approachable for guidance and support. I regularly conduct training sessions for my team, focusing on both theoretical knowledge and practical skills. My goal is to build a team that’s not only proficient in protocol but also adept at handling on-site challenges.” Question 5: How do you communicate complex information to study sponsors and investigators?Answer: “I believe in clear, concise communication. When dealing with complex information, I break it down into easily digestible segments. For instance, I once created a simplified guide on a new protocol amendment for our sponsors and investigators, which was well-received for its clarity.” Question 6: How do you ensure study site compliance with regulations?Answer: “Regular audits and training sessions are key to ensuring compliance. For instance, during one audit, I identified a minor non-compliance issue and immediately addressed it with additional training and process adjustments, ensuring no recurrence.” Question 7: Can you provide an example of resolving a significant challenge during a study?Answer: “In a study where patient recruitment was lagging, I implemented a revised strategy involving community outreach and collaboration with local healthcare providers. This not only improved recruitment rates but also enhanced the diversity of our study population.” Question 8: How do you maintain accuracy in study documentation and reporting?Answer: “I ensure that all documentation is updated promptly and accurately. For instance, I maintain a systematic approach to filling out case report forms and ensure all study documentation is audit-ready at any point.” Question 9: Do you have experience in site financial management?Answer: “Yes, in my last role, I was responsible for overseeing the financial aspects of our sites. This involved monitoring budgets, reviewing invoices, and ensuring that all financial dealings aligned with the clinical trial agreement.” Question 10: How do you stay updated with industry best practices and regulations?Answer: “I regularly attend industry conferences and participate in webinars and training. Staying updated is crucial in our field, and I make it a priority to be aware of the latest trends and changes in clinical research regulations.” ConclusionPreparing for a CRA interview requires a deep understanding of clinical trial processes and the ability to articulate experiences and skills effectively. The answers provided here are designed to help candidates showcase their expertise and readiness for the challenges of a Senior CRA role. Remember, personalizing these answers with your unique experiences will make your responses more impactful. Conclusion The interview for a Clinical Research Associate position is an opportunity to showcase your expertise, experience, and passion for clinical research. By understanding the intricacies of the role, reflecting on your experiences, and staying informed about the industry’s future, you can present yourself as a well-rounded and forward-thinking candidate. Remember, your ability to navigate complex scenarios, your commitment to ethical and accurate research, and your understanding of the evolving nature of clinical trials will set you apart as a promising CRA.

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Types of site visits by CRA

Types of site visits by CRA

A Clinical Research Associate (CRA) can be employed directly by the sponsor companies (such as Pharmaceutical, Biotechnology, or any research company) of clinical trials or by Contract Research Organizations (CROs), also referred to as Clinical Research Organizations. According to ICH GCP, these organizations conduct clinical trials on behalf of the sponsor companies. Let’s learn about the types of clinical trial site visits conducted by CRAs. The primary responsibility of a CRA is to ensure that the rights, safety, and well-being of subjects participating in clinical trials are protected. The CRA acts as the main mode of communication between sponsors and the site. A Clinical Research Associate qualifies, initiates, monitors, and closes the clinical trial sites assigned to him/her. Based on their level of experience, CRAs can be hired at various levels such as CRA Level I, II, III, and as Senior CRA by employers. Some common on-job responsibilities of CRAs include: Required skills for a Clinical Research Associate include: The process of outsourcing and flow in clinical trials involves: I am listing the types of Clinical Trial Site Visits conducted by CRAs, which may vary depending on industry practices: In conclusion, these are the basic types of Clinical Trial Site Visits conducted by CRAs. I will provide detailed information about each visit in upcoming articles. Article By: Shahenaz Karadesai

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Clinical Research Associate: Roles & Responsibilities

Introduction Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the roles and responsibilities of a CRA and highlight the significance of this career in the realm of clinical research. A Clinical Research Associate is a professional who monitors the administration and progress of a clinical trial (a research study that tests how well new medical approaches work in people). Typically, CRAs hold a degree in pharmacy, life sciences, nursing, or a related field, combined with substantial knowledge of clinical research protocols. They are the linchpins in the development of drugs, biologics, and medical devices, bridging the gap between the clinical trial process and regulatory compliance. Key Responsibilities of a Clinical Research Associate 1. Site Selection and Preparation CRAs are involved in selecting suitable sites for clinical trials, and assessing the capabilities of a site to conduct the trial. This involves evaluating the staff’s qualifications, the facility’s equipment, and the site’s patient population. They also play a key role in preparing the site for the study, ensuring that each site has the necessary materials and training to conduct the trial according to protocol. 2. Protocol Development and Implementation CRAs contribute to developing the clinical trial protocol, a document that outlines the objectives, design, methodology, statistical considerations, and organization of a trial. They ensure that the trial is implemented as per the protocol and that any deviations are documented and justified. 3. Subject Recruitment and Consent A crucial aspect of a CRA’s role is facilitating the recruitment of subjects for the trial. They ensure that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements. 4. Monitoring Clinical Trials CRAs regularly visit trial sites to monitor the progress of the trial. They verify that the clinical trial data recorded by investigators is accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. 5. Ensuring Compliance CRAs ensure that clinical trials comply with regulatory standards and ethical guidelines. They are responsible for understanding and keeping up to date with regulations and guidelines, such as those set by the FDA or EMA. 6. Data Management and Reporting Managing and overseeing the data collected during clinical trials is another key responsibility. CRAs review data for accuracy and completeness and assist in preparing reports on the trial’s findings. Challenges Faced by Clinical Research Associates CRAs often face challenges such as managing responsibilities across multiple trial sites, ensuring data integrity, and adapting to constantly changing regulatory environments. Problem-solving skills, adaptability, and a keen eye for detail are essential traits for success in this role. The Future of Clinical Research Associates The role of a CRA is evolving with advancements in technology and changes in the regulatory landscape. CRAs are increasingly involved in virtual or remote monitoring of trials, using digital tools to manage and oversee trial progress. As the field grows, so do the career paths and advancement opportunities for CRAs. Conclusion Clinical Research Associates play a critical role in the success of clinical trials. They ensure that trials are conducted ethically, efficiently, and in compliance with regulatory standards. The role of a CRA is not only challenging and demanding but also highly rewarding, contributing significantly to the advancement of medical research and patient care.

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Clinical Research Coordinator: Role and Responsibilities

Introduction The role of a Clinical Research Coordinator (CRC) is pivotal in the landscape of clinical trials and research. These professionals are primarily responsible for managing the daily operations of clinical studies, ensuring compliance with regulatory requirements, and maintaining high standards of care and accuracy. Key Responsibilities of a Clinical Research Coordinator A Day in the Life of a Clinical Research Coordinator 8:00 AM: The day starts with a review of the schedule. The CRC checks appointments with study participants and prepares for their arrival. 9:00 AM: A participant arrives for a follow-up visit. The CRC conducts an informed consent process, reviews the participant’s medical history, and answers any questions. 10:30 AM: Time for data entry. The CRC updates the study database with the latest data collected from participant visits. 12:00 PM: Lunch break, often used to catch up on the latest research and developments in clinical trial management. 1:00 PM: The afternoon is dedicated to a team meeting with the principal investigator and other staff. They discuss the progress of the study and address any issues. 2:30 PM: The CRC prepares documents for an upcoming IRB meeting, ensuring that all regulatory aspects of the study are in order. 4:00 PM: A session is held with a new participant for screening. The CRC explains the study protocol, assesses eligibility, and schedules the next visit. 5:30 PM: Before wrapping up, the CRC checks emails and responds to queries from participants and other team members. 6:00 PM: The day ends with a plan for the next day, including participant visits, data analysis, and team coordination. Conclusion A Clinical Research Coordinator plays a vital role in the success of clinical trials, balancing administrative, regulatory, and patient-care responsibilities. Their typical day reflects the diverse and dynamic nature of their job, ensuring the smooth and ethical conduct of clinical research.

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Ethics Committee Coordinator: Role and Responsibilities

An ethics committee coordinator typically plays a crucial role in managing the activities and administration of an ethics committee, which is often established within organizations like hospitals, universities, or corporations to oversee ethical standards and practices. The specific responsibilities of an ethics committee coordinator can vary depending on the organization but generally include: This role requires strong organizational, communication, and analytical skills, as well as a good understanding of ethical principles and relevant laws and regulations.

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Top Guidance Tips for CLINICAL RESEARCH Freshers

Amaan Ansari COMPLETED B PHARM FROM NORTH MAHARASHTRA UNIVERSITY, HAVING 3.5+ YEARS OF EXPERIENCE IN CLINICAL DATA MANAGEMENTON A PERSONAL FRONT, I AM KEEN TO HELP AND GUIDE INDIVIDUALS IN CLINICAL DATA MANAGEMENT AND PHARMACOVIGILANCE.ALSO ON GENERAL ASPECTS SUCH AS COMMUNICATION SKILLS, INTERPERSONAL SKILLS, INTERVIEW TIPS, RESUME WRITING, EMAIL WRITING. This content is copied from Amaan Ansari’s LinkedIn posts. Please read the post carefully as Amaan gave some light to a particular topic. Many Life Sciences graduates/postgraduates also Pharm graduates/post graduates especially freshers are looking for opportunities in #clinicaldatamanagement and #pharmacovigilance etc. For entering these fields many individuals are additionally pursuing PG Diploma in CDM and PV and investing thousands of rupees in it. The question here is, are these certificates compulsory to enter these fields?The answer is “No”. If you are pursuing it’s good but it’s not compulsory for entering PV or CDM. As a fresher you just need to:1) Be thorough with your educational background.2) Develop communication skills.3) Gain basic knowledge of CDM and PV through Slide Share ppt, Google ppts. etc.4) Prepare a good CV5)Approach people working in PV and CDM for professional guidance. Remember one or the other day you will be selected. If you are rejected anywhere there is always a better opportunity waiting for you. The majority of Pharmacy and Life Sciences freshers are confused about how to start their careers. How to start your career Below are some important points: If a person is posting any job opportunities from his/her organization it is always as a helping hand. A person will post whatever official email he gets from his organization let it be for freshers/ experience. He can’t post anything from his end. Also if you are eligible for the particular job role the most he/she can do is Refer you and guide you, that’s it what we can do. Getting interview calls and getting selected is not in our hands. I know as a fresher it’s not easy to get a chance. But have faith in yourself and prepare yourself and be the best, hopefully, One day you will get your dream job. So keep learning and Helping each other. I try to reply to every person who DMs me, sometimes due to an overload of DMs there might be a delay in reply, but I assure you that I reply. Please note this is a generic scenario. It may vary from person to person.vI applied for many jobs but no response!! There is always a common question among freshers that we are applying for many job opportunities for the last 5/6 months but we are not getting any calls. Below may be some of the reasons. Please remember there will always be a position that suits your profile, you have to just look for it, read the job eligibility and job description properly, and apply for it. Job openings on the company portal The below topic is regarding applications for job openings on the company portal. Below are some key points: Email Writing There is a common question among #freshers that we are emailing #cvs to many people but then to we are not getting any calls. Below are some reasons: Please note that A Proper email with a good #subjectline#body#cv is always appreciable. Telephonic/Virtual Interview Below the topic is a Telephonic Round of Interviews with #hr Many of us are waiting for getting calls from #recruiters, the question here is are we ready for it. Below are some key points regarding HR interview calls: Hopefully the above would help all. Interview in CDM Below are some basic topics that you need to be prepared for if you are looking to make your career in #clinicaldatamanagement. # Finally and Most Important-Basic Info of Organization you are looking for. -Establishment year -Number of Employees -CEO of Organization etc. -Mision and Vision of the Organization. Why do you want to work in Our Organization.-Why should we hire you.-Where do you see yourself after 5 years.-What are your career goals. All other basic Aptitude questions. Guidance to check the authenticity of job posts on LinkedIn Are all Job Openings posted for freshers Correct or its Fake? Always remember to review a person’s profile before commenting on his/her post or sending him/ her a connection request. Nowadays it’s been observed that people working in a particular organization are posting Job openings of some other organizations and posting just that ” DM me or Inbox me for details”. Think twice if a person is not in that Organisation He/ She can’t give you details and can’t refer you to that organisation. Such kinds of posts are just for making connections and misguiding people. But! If a person is posting some other organization’s openings and giving you a link to apply which is directing you to that organization’s page then no issues in such cases. Interview in PV This topic is #interview in #pharmacovigilance#pv Below are some basic topics that you need to be prepared if you are looking to make your career in #pharmacovigilance#pv Technical Round(Face-to-Face) Most Important Pharmacology in detail (Basic Info of All Classes of Drugs, MOA, Classification etc) The Basic Info of the Organization you are looking for. All other basic Aptitude questions. Which domain has a Good Career for Pharmacy or Life Science graduates post graduates? There are many questions in the minds of freshers regarding their Careers. Q1) Which field has better growth? Answer- Growth always depends on personal skills, knowledge, and quality of work. It is independent of the Field. You should always be the best in your field. Q2)Which field has a better package? Answer- The package depends on many factors. It also depends on Personal skills, Domain related experience, and knowledge. All domain has equal package offer. Q3) Which field has less workload etc.? Answer- There is workload everywhere and No workload anywhere. It’s totally dependent on the individual to balance and handle it. It is independent of any domain or company. Q4) Which field is more interesting? Answer- Choose a field in which you are good and whatever is your passion. Working in a domain in that you

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