Clinical Research Coordinator (Zydus)

Roles and Responsibilities

Job Description

• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study

• Coordinates with sponsors/Doctors/Vendors/Internal departments to complete the research related activity.

• Keep track of study activities to make sure compliance with protocols and with all related local, state, and national regulatory and institutional polices.

• Ensure the filing and maintenance of trial master file & all regulatory documents

• Prepared and processed all documentation for Institutional Review Board (IRB), submissions, notification, and approval from IRB. Prepare study progress report of all studies which are approved by IEC.

• Prepare trial-related paperwork such as visit checklist; adverse event reports other source notes.

• Coordinates and attends sponsor Site Selection visits, monitoring visits, and study close out visits and auditing visits.

• Assists the PI in development of necessary materials to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.

• Extracts data from patient file (Source documents) in a timely manner &Enter study data into the applicable database and review them against the patient’s medical record for completeness and accuracy. Responds to data clarification requests in a timely manner.

• Maintains a excel sheet, tracking updates to database of all subjects enrolled on clinical trials

• Working closely with the PI in the informed consent process by communicating with study subjects about protocol.

• Meet with patient for each visit and maintain effective communication with patient and informed them study aspect which is relevant to them

• Record adverse event and side effect information and consult with investigators. Prepare SAE report and notify to EC, Sponsor & DCGI as per requirements.

• Dispense study medication as per protocol requirements and maintain accountability records.

• Collect, process, and ship blood/urine specimens at scheduled patient visits

• Gather lab results or procedure reports, and assure the investigator reviews them in a timely manner.

• Collect supplies from sponsors and ensure everything is accounted for such as lab kits, ancillary supplies, and investigational medication.

• Participate in web conferences and teleconferences for each study protocol in order to stay updated.

• Attain Investigator meetings for protocol training and report pertinent information back to research team members.

• Coordinates approval of new study agreements and finalization contracts.