Experience

0 - 2 Year(s)

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

Schedules study subject visits and complete all protocol related procedure

Working closely with the PI, CRC participates in an integral way in the informed consent process by communicating clearly with potential study subjects about protocol. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol in order to be able to answer all questions pertaining to the study posed during the informed consent process.

Coordinates approval of recent study agreements and contracts.

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

Responds to data clarification requests in a timely manner.

May attend Investigator meetings requiring travel and report pertinent information back to research team members.

Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement

Maintain subject screening, enrollment, drug accountability logs and protocol deviation logs.

Ensures that all materials for each clinical trial protocol are available for subject enrollment.

Randomizing the subjects through IVRS or IWRS

Maintain excel sheet, tracking updates to database of all subjects enrolled on clinical trials.

Completes case report forms paper or electronic.



Extracts data from patient file (Source documents) in a timely manner.

Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits.

Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.

Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.

Performs specimen processing and shipment of biological specimen to local or central labs.

Assists the Principal Investigator in submission of accurate and timely closeout documents to IRB/IEC and applicable regulatory requirement.

Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.

Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research.

Ethics Committee

Coordinate with Ethics Committee member secretory and members to schedule and conduct ethics committee meeting according to EC SOPs.

Preparing agendas, distributing study documents, preparing minutes of meeting, follow up action were required and approval letters

Filing and archiving all the study documents submitted for EC approvals

Submission of progress reports as per EC SOPs of all the studies

Promptly reporting adverse events

Administrative activities

Assist in CME programs

Cultural activities

Walkathons

📌 ASSISTANT - CLINICAL RESEARCH (Bengaluru)
🏢 Sankara Eye Foundation
📍 Bengaluru