Clinical Research Associate

Overseeing the management of clinical trials across the site to ensure they progress in accordance with contract terms and defined quality standards, protocols, SOPs, GCP, and relevant guidelines to meet local regulations.

Communicating project scope, timelines, goals, technical details, and input from the Director/Project Manager to the sites throughout the project. Support HOD/Project Manager in operational inputs for the conduct of study. Support in investigator payments and other vendor payment.

Conduct Feasibilities, document and maintain them including trackers, if any as per SOPs and under the supervision of PM/Designee.

Assisting the Project Manager in developing the project plan, monitoring plan, and other documents as per the requirements of the project and sponsor.

Identifying, categorizing, evaluating, and updating the potential Investigators and Vendor list with CTA.

Performing Site Initiation visits to ensure that each site has the necessary trial materials. Ensure the report and follow-up letter are sent to the site with the timelines and follow-up for pending queries or issues as per agreed timelines.

Preparing & completing the checklist for site activation & ensuring IMP readiness.

Conducting interim monitoring visits to assess protocol adherence, monitoring plan compliance, and the protection of human rights. This includes source data verification, CRF collection, IP accountability, and report preparation. The MV report and follow-up letter should be finalized within the agreed timelines and pending queries or issues to be followed up effectively for closure as per agreed timelines.

Review of protocol, e-CRF, Lab Manual, Informed Consent Form, and all other project-specific documents to familiarize and manager site management effectively.

During monitoring visits, ensure that the sites are notified, and subsequently notify EC. Verify the cross-notification process for SAE as per the CDSCO checklist, both to the DCGI on behalf of the sponsor and to the other participating sites.

Regular Review of PSSV, SIV, SMV reports for timely closure of issues.

Assuring readiness of Logs, Laminates, and File indexes for the organization of document and presentations for training.

Preparing and submitting the study dossier to the Ethics Committee and sites.

Preparation and review of responses to QA audit and sponsor audit observations.

Conduct Site Close-out Visits as per SOP and responsible for ensuring data query resolution, updated site files, study files, investigational product reconciliation etc.

Circulating the final study report to the respective sites for Ethics Committee notification and archival.

Follow-up with sites for patient recruitment, patient follow-up, activities required to perform as per protocol and resolution of issues.

Coordinate and distribute clinical study material to study sites.

Assisting with investigator meetings, including preparation, liaison, presentations, and follow-up.

Maintaining the trial master file or electronic TMF and other applicable checklists or documents as per SOP, including reported Adverse Events, annual IEC/IRB reports, EC Communications, and Correspondence. All TMFs/eTNFs to be ready for audit or inspection all the time.

Supervise, Train and mentor CRAs, CTAs or other CO staff.

Preparing the project for archival as specified in the contract upon study.

Individual Training Files to be up-to date and always audit ready.

Ensure study data is entered in study specific EDC tools and reviewed as per the protocol and other relevant documents and ensure all queries are resolved within the specified timeline for data cleaning and database lock

PSSV, SIVs, SMV and SCVs will be performed along with other experienced CRAs/Designee as a part of CRA Training. Performing these visits independently is upon approval of HOD.

Ensure Sites are audit or inspection-ready all the time and assist in audit/inspection readiness and in CAPA as necessary.

Support departmental vendor assessment and planning etc.

Contribute to the development of Standard Operating Procedures (SOPs) and working practice.

Familiarize with ICH-GCP, appropriate regulations, relevant SOPs, and internal tracking systems.

Willingness to travel for job-related activities, (Expected Travel

Responsible for maintaining and keep up to date employee training file

Fulfilling other duties as assigned by HOD/CEO.

Job Type: Full-time

Pay: ₹350,000.00 - ₹600,000.00 per year

Education:

• Master's (Preferred)

Experience:

• Clinical research: 2 years (Preferred)

Work Location: In person