Senior Clinical Research Associate
2 days ago
🏢 In-office - Bay Area
Description
• A Senior Clinical Research Associate will work closely with clinical operations and the cross-functional study execution team to implement all aspects of clinical trials to support multiple clinical programs. • The position will liaise with clinical sites, central labs, biomarker labs and internal stakeholders to ensure successful execution across Adicet’s clinical programs. • The (Sr.) CRA is primary point of contact for clinical sites and will act as a site monitor who is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs • Conduct study site evaluation visits (PSSV), site initiation visits (SIVs), routine monitoring visits (IMVs), and site close out visits. • Perform various study start-up activities: work with sites to collect appropriate regulatory documents, support/assist with the negotiation of contracts and budgets, perform training for clinical sites to ensure proper data collection and report any potential safety-related events, manage the site's activities during study maintenance, and closing research activities at the sites once the study has concluded • Develop collaborative relationships with investigative sites, and study vendors • Track enrollment status reports to ensure study sites stay on track to meet enrollment goals • Track study-specific items to ensure all required information regarding site issues, deviations, and CRF status are kept current • Verify proper management and accountability of Investigational Product • Develop and update multiple study tracking documents: subject tracking, essential document tracking, and sample collection/management • Perform Serious Adverse Event (SAE) reconciliation and work with study sites and cross functional teams to resolve discrepancies • Collect, track and review for completeness site regulatory documents for TMF filing • Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation • Other duties as may be assigned • Ability to travel up to 50 - 75%
Requirements
• BS with 2+ years’ experience in pharmaceutical or biotech industry • Experience working directly with clinical sites • Solid understanding of cGMPs, clinical operations, and drug development processes • Detailed oriented with ability to work in a fast-changing environment • Excellent interpersonal, oral, and written communication skills • Superior organizational skills with attention to details • Ability to work with little or no supervision • Strong collaboration and excellent team skills
Benefits
• Onsite gym • Various fitness options • Zero-cost onsite parking • Electric vehicle charging stations • Free shuttle( Caltrain) • Company subsidized lunches (delivered onsite daily) • Fully stocked breakrooms
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