Sr. Clinical Research Associate

Senior CRA

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.