Sr. Clinical Research Associate

Senior CRAThe 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 ResponsibilitiesSite & Study OversightServe 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 & DesignContribute 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 & ComplianceMaintain 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 CollaborationPartner 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.)RequirementsRequired QualificationsMinimum 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 QualificationsExperience 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.