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Be ready to walk through senior CRA monitoring examples: how you prepared for an IVD or device-adjacent visit, resolved data-quality issues, and partnered with labs or central functions. Expect scenario questions on CAPA, remote vs on-site monitoring, and working inside an FSP model with Lifelancer as the contracting employer.
Strong fit if you already operate as a senior CRA, prefer FSP structure, and can own IVD study quality across U.S. sites. Thinner fit if you need a named city package, heavy remote-only work, or a fully mapped cert/salary story—those details are not in the supplied DATA.
As a Senior CRA 2 on an FSP assignment for invitro diagnostics at Lifelancer, a typical day centers on monitoring IVD clinical or performance studies: reviewing protocols and source data, checking site readiness and sample/lab workflows, tracking deviations and CAPAs, and escalating risk to the project lead. You would coordinate with investigators, lab partners, and the sponsor-facing FSP team, document visits and remote reviews in the trial systems, and help keep timelines, data quality, and inspection readiness aligned with IVD regulatory expectations.
Build depth in GCP, IVD/clinical performance study monitoring, TMF/eTMF hygiene, risk-based monitoring, and clear site communication. Strengthen protocol deviation handling, lab/sample chain-of-custody awareness, and FSP multi-sponsor coordination. No certification package or costs were supplied in CERTS for this listing.
The listing marks remote as no (0) and locations the work in the United States; confirm travel and hybrid expectations with the recruiter.
Functional Service Provider setups place CRAs with a sponsor or program under Lifelancer’s employment model; day-to-day systems and SOPs often follow the client while HR sits with Lifelancer.
No cert family or priced resources were provided in CERTS for this job; rely on the formal posting and hiring manager for mandatory credentials.
Website: lifelancer.com
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Sr. CRA 2, FSP - Invitro DiagnosticsLifelancerUnited States (On-site) About the Role The Sr. CRA 2 role at Lifelancer involves critical responsibilities in clinical trial monitoring and management. This position requires a high level of expertise, ensuring compliance with regulatory standards and maintaining the integrity of study data. Responsible for routine and close-out site monitoring, including pre-study and initiation visits Maintain study files and liaise with vendors as necessary Ensure proper materials and instructions are provided to protocol staff Verify informed consent procedures and adherence to regulatory requirements Monitor data for missing or implausible entries on Case Report Forms (CRFs) Undertake feasibility work when requested, including SAE reporting and production of reports/narratives Independently perform CRF review and query generation/resolution against established guidelines Key Responsibilities You will be responsible for all aspects of study site monitoring, registry management, and on-site general oversight. This includes ensuring the safety and rights of participants, maintaining data integrity, and performing various administrative tasks as assigned. Ensure proper materials and instructions are provided to protocol staff Verify informed consent procedures and adherence to regulatory requirements Monitor data for missing or implausible entries on Case Report Forms (CRFs) Undertake feasibility work when requested, including SAE reporting and production of reports/narratives Independently perform CRF review and query generation/resolution against established guidelines What You Bring Candidates should have a minimum of 4+ years of experience in clinical research, with specific expertise in monitoring. A strong background in clinical trial management, data integrity, and regulatory compliance is essential. Minimum of 4+ years of experience in clinical research Experience in site monitoring, CRF review, and query resolution Familiarity with regulatory requirements and standards Strong organizational and communication skills A proven track record of ensuring data integrity and compliance About the Company Lifelancer is a leading provider in clinical research, dedicated to advancing medical science through high-quality clinical trials. Our team is committed to excellence and innovation in healthcare. Next Steps To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.
Generated for personal interview prep · 2026-08-09 UTC · getajob.ai