Hi, I am Pooja Madhukar Parab. I am Msc bioanalytical scientce graduate. I am CRC at Tata Memrial Hospital, Mumbai. Here I am writing my 1st blog on My Day to Day Life as Clinical Research Coordinator.
Well, you all know that, Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
I will not talk about theoretical part here. I want to walk you through my day to day life as CRC.
As a CRC my day starts at 9.00 am. My work is completely based on the phase of trial e.g. Initiation, recruitment, or closing of the trial. I am writing this article for the recruitment phase trial, patient recruitment is going on.
The 1st work which I do is checking the emails. I might have received emails from CRO- CRA/CTA/Managers, sponsors, Principle Investigators or any other stakeholder.
I check patient visits also if any. Considering the patient recruitment priority, I visit the hospital OPD to confirm the eligible patients where sub investigators prescreen the patients. I always prepare a plan for each patient visit as per the protocol requirement to avoid protocol deviations.
If the patient is eligible, the PI process for ICF as per applicable guideline. As coordinator, my work is to coordinate all the patient process. After completion of ICF consent, I connect the laboratory and other applicable department e.g. X-ray, ECG, or any other department.
During this process, I start documenting the ICF narrative. ICF narrative is a key element to document the entire process of ICF and screening.
Once this coordination complete, I schedule my work for eCRF data entry. As we are using the EDC system, hence I transcribe all the source data to eCRF. eCRF is an electronic case report form where we enter the subject data like screening visits i.e laboratory values, vital signs, and trial indication details or, visit 1-N number of visit details, EOF (end of treatment).
Apart from this I update screening and pre-screening logs, check if all the Case Report Forms, ICFs, other questionnaires are complete and signed by PI. All the visits are completed by patients.
Inform protocol deviation or protocol violation if any to PI and report to IEC, Maintain all trial related documents like Protocol Submission Report, ICFs, CRFs and protocols with updated versions, protocol approval letter and other essential documents in site master file.
Review budget and update PI. Submission of continuing review application to IEC every 6 months. I also help PI for submitting Protocol submission form and complete CTRI registration for new studies. Receive calls from patients, PIs, Co-Is and reply their queries.
Other activities include to attain meetings or trainings with PI. To check if stationary and copies of ICF, CRF and questionnaire are in stock. To courier documents to other sites. My day ends by 5.30 pm, most of the time days are hectic.
During this COVID-19 pandemic patients were not able to visit hospital, patients call me and I answer their queries by discussing with PI.
Also as a COVID-19 precautionary measure all the coordinators are assigned COVID-19 screening duties twice or thrice a month, with PPE kit worn. I measure temperature of patients and their relatives or ask them Hospital’s standard COVID-19 questions mark their answers before they enter hospital or navigate patients inside hospital.
I stay in continues contact with CRAs also for site monitoring, site close out, qualification or initiation visits.
In a nutshell, as a CRC, my work is screening process, ICF narrative, source documentation, eCRF data entry, Shipment management, communication with CRO and site file management.
This is only overview of my work as CRC. If you want me write insights, let me know in comment box.
Thank you for reading blog on My Day to Day Life as Clinical Research Coordinator (CRC).
Writer : Pooja Parab