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Sr. Clinical Research AssociatePrinceps Technologiees • south san francisco, CA, us
No longer accepting applications
Sr. Clinical Research Associate
Princeps Technologiees • south san francisco, CA, us
30+ days ago
Job type
- Full-time
Job description
The Senior CRA independently manages a small-to-medium clinical study, or takes on significant end-to-end responsibility on a larger study under the direction of a Sr. CTM or Associate Director. This role serves as the primary escalation point for site-level issues and owns site oversight, monitoring, and vendor coordination, while also contributing upstream to protocol development, study start-up, and TMF quality. This requisition includes placement into a general CRA/Sr. CRA pool as well as two named studies: the Twin Peaks program and the ACCG-2671 amylin MAD (multiple ascending dose) study.
Key Responsibilities
Site & Study Oversight
- Serve as the primary escalation point for assigned clinical sites, resolving issues related to protocol compliance, enrollment, and site performance.
- Oversee CRO-conducted monitoring activities, including timely review and approval of monitoring/site visit reports.
- Lead or support site contract and budget negotiations, ensuring alignment with study timelines and financial parameters.
- Provide oversight of study vendors, including IRT (Interactive Response Technology), eCOA, cardiac safety, and patient reimbursement vendors, ensuring deliverables meet study requirements.
Study Start-Up & Design
- Contribute to protocol development and amendments, providing operational and site-level feasibility input.
- Support CRF (Case Report Form) design and User Acceptance Testing (UAT) to ensure data collection tools meet study needs.
- Support development of study budgets and timelines during start-up and throughout the study lifecycle.
- Support vendor RFP processes and bid-defense meetings as needed.
Quality & Compliance
- Maintain and QC the Trial Master File (TMF) to ensure inspection readiness and compliance with ICH-GCP and applicable regulations.
- Ensure site-level and study-level activities are conducted in accordance with the protocol, SOPs, and regulatory requirements.
- Identify and escalate risks or quality issues to the CTM/Associate Director in a timely manner.
Cross-Functional Collaboration
- Partner with Clinical Trial Managers, Data Management, Regulatory, and other cross-functional stakeholders to support study execution.
- Provide regular study status updates and escalate emerging risks to leadership.
Assigned Studies (Named Requisitions)
- Twin Peaks Program
- ACCG-2671 – Amylin Multiple Ascending Dose (MAD) Study
(Candidates may also be considered for placement into the general CRA/Sr. CRA resource pool based on team needs.)
Requirements
Required Qualifications
- Minimum 4 years of clinical trial management experience from a sponsor, CRA/field monitoring, or CRO perspective (global trial experience a plus).
- Bachelor's degree in a scientific discipline (e.g., life sciences, nursing, or related field).
- Demonstrated experience with site management, monitoring oversight, and vendor coordination.
- Experience supporting protocol development, CRF design/UAT, or study start-up activities.
- Strong working knowledge of ICH-GCP and applicable regulatory requirements.
- Excellent written and verbal communication skills; strong organizational and problem-solving abilities.
- Willingness and ability to travel approximately 30%.
- Must be able to work core PST hours.
Preferred Qualifications
- Experience with early-phase studies (e.g., MAD/dose-escalation designs) and/or metabolic/endocrine therapeutic area experience (relevant to ACCG-2671).
- Prior experience with TMF QC and inspection readiness activities.
- Experience with IRT, eCOA, or cardiac safety vendor oversight.
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Sr. Clinical Research Associate • south san francisco, CA, us
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