What are the responsibilities and job description for the Clinical Research Associate (CRA) position at Gandiv Insights LLC?
Job Title: Clinical Research Associate (CRA)
Location: Boston, MA
Employment Type: W-2 Contract
Job Description
The Clinical Research Associate (CRA) will independently monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements. The CRA will support study start-up, execution, and close-out activities while ensuring data quality, patient safety, and inspection readiness.
Key Responsibilities
- Conduct site monitoring visits (PSV, SIV, IMV, COV) per Clinical Monitoring Plan.
- Review and maintain essential documents including protocols, ICFs, CRFs, DOAs, ISF, and regulatory files.
- Perform source data verification (SDV) and ensure data integrity per ALCOA principles.
- Prepare monitoring reports and follow-up letters in a timely manner.
- Ensure TMF/eTMF accuracy and site audit readiness.
- Manage investigational product accountability and reconciliation.
- Support patient recruitment, site training, and investigator meetings.
- Collaborate with cross-functional teams and ensure compliance with SOPs and GCP.
Qualifications
- Bachelor’s degree in Life Sciences or related field (Master’s preferred).
- 3–5 years of CRA monitoring experience.
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
- Hands-on experience with EDC, CTMS, eTMF systems.
- Experience in Oncology, CNS, or Medical Device trials preferred.
- Excellent communication, documentation, and organizational skills.
Please share your updated resume to jyothi.t@gandivainsights.com