Senior Clinical Research Associate (Sr. CRA)

CBCC Global Research

5 - 8 years

9 - 14 Lacs

ahmedabad

Posted:1 week ago| Platform:

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Skills Required

cra clinical research clinical research associate site monitoring senior cra ndctr siv cro sdv clinical operations oncology trials closeout ip accountability site selection tmf clinical trials site initiation imv gcp

Work Mode

Work from Office

Job Type

Full Time

Job Description

Senior Clinical Research Associate (Sr. CRA)

Location:

Senior Clinical Research Associate

Key Responsibilities

Conduct SQV, SIV, IMV, closeout visits, and pre-audit visits.
Perform end-to-end site management ensuring protocol, GCP, and regulatory compliance.
Perform SDV/SDR, review CRFs/eCRFs, IP accountability, and site file review.
Prepare monitoring visit reports within defined timelines.
Assist PM in project planning, communication, and study updates.
Coordinate with sites for DCF resolution, SAE reporting, PDs, EC communications, and study progress reports.
Maintain ongoing communication with site teams for compliance and issue resolution.
Perform centralized/back-office monitoring as required.
Maintain Trial Master File (TMF) and ensure document completeness.
Participate in investigator meetings and follow-up activities.
Support closeout activities: query resolution, IP reconciliation, file completion, archival readiness.
Ensure study archival as per contract and SOPs.
Follow quality standards and support audits.
Train and mentor junior clinical staff and new recruits.

Key Skills Required

Strong experience in
oncology site monitoring
(mandatory)
Knowledge of GCP, NDCTR 2019, ICH guidelines
Excellent communication, documentation, and problem-solving skills
Ability to manage multiple sites and work independently
Strong understanding of monitoring processes, TMF, and site operations

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