Senior Clinical Research Associate

Senior Clinical Research Associate (Sr. CRA) Reports To: Sr. Clinical Trial Manager (CTM) or Associate Director, Clinical Operations Travel: ~30% Work Hours: Must be available during Pacific Standard Time (PST) core hours Role Summary 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 escape any 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 elevate emerging risks to leadership. Assigned Studies (Named Requisitions) (Candidates may also be considered for placement into the general CRA/Sr. CRA resource pool based on team needs.) 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. 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. #J-18808-Ljbffr princeps technologies