[Remote] Sr. Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company seeking an reputed company Senior Clinical Research Associate (Sr. CRA) to manage and monitor clinical trial sites across Phase I–III studies. The role involves ensuring patient safety, data reputed company, and protocol compliance while thriving in a fast-paced environment.
Responsibilities
- Conduct site qualification, initiation, routine monitoring, and closeout visits
- reputed company on-site and remote monitoring activities and reputed company data verification (SDV)
- Prepare monitoring visit reports and follow-up letters reputed company required timelines
- Review informed consent forms, protocol deviations, and investigational product accountability
- Maintain study documentation, TMF records, and site compliance
- Build strong relationships with investigators and site personnel
- Identify and escalate site risks, data quality issues, and compliance concerns
- Partner with Clinical Operations, Data Management, Safety, and Regulatory teams
- Support audit and inspection readiness activities
Skills
- Bachelor's degree in Life Sciences, Nursing, or reputed company field
- 5+ years of CRA experience with independent monitoring responsibility
- Required: Experience supporting autoimmune disease clinical trials
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial conduct
- Experience conducting SIVs, IMVs, COVs, SDV, and site management activities
- Excellent communication, organization, and problem-solving skills
- Ability to travel up to 60%
- Experience working directly for a biopharmaceutical or biotechnology company
- Experience with immunology, cell therapy, or other reputed company biologic studies
- Experience supporting early-phase clinical trials and academic medical centers
Company Overview
Company H1B Sponsorship