Sr. Clinical Research Associate/Clinical Trial Manager

Reporting to the Sr. Director, Clinical Operations, the Sr. Clinical Research Associate/Clinical Trial Manager collaborates within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, GCP, SOPs, and applicable regulations. Responsible for performing quality study oversight processes, including monitoring communications with site staff and clinical vendors, and reviewing monitoring trip reports.

•       Partner with the Clinical Operations Study Lead and cross-functional team to support clinical studies from planning and start-up through execution, maintenance, and close-out in accordance with assigned SOPs, ICH/GCP, and corporate and departmental goals.

•       Lead operational management for assigned regions and sites by monitoring performance metrics, identifying and mitigating risks, driving escalations and action-item closure, and representing regional performance in study team and cross-functional discussions.

•       Serve as the primary sponsor contact for assigned investigators and study sites, building strong relationships and supporting effective communication and issue resolution.

•       Lead aspects of vendor management for the CRO and other key vendors (IRT, imaging, central and specialty labs, etc.), establishing expectations, ensuring deliverables are met, performance measures are maintained, and escalating as needed; address performance gaps and drive corrective actions to closure.

•       Provide oversight of CRO monitors by reviewing monitoring documentation, evaluating monitor and site performance, conducting oversight or co-monitoring visits as needed, and identifying cross-site or systemic risks.

•       Maintain and analyze study tracking tools and operational metrics, including site start-up, screening, enrollment, study visits, data entry, query resolution, and monitoring activities.

•       Contribute to the development and maintenance of study documents, including informed consent forms, site training materials, CRFs, monitoring plans, source document templates, protocols, investigator brochures, and regulatory submission materials under the direction of the study lead.

•       Ensure the Trial Master File is complete, current, accurate, and inspection-ready, and drive resolution of missing or deficient documentation.

•       Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.

•       Apply ICH E6(R3) Good Clinical Practice principles, including quality by design, risk-proportionate oversight, critical-to-quality factors, participant protection, and reliable trial results, across study activities.

•       Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to the Study Lead.

•       Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and drug questions, safety, regulatory, and legal questions

•       Oversee operational study needs, including clinical supplies

•       Participates in the review and negotiation of site budgets and contracts

•       Support and participate in Investigator Meetings and other study-related meetings, as required.

•       Promote a collaborative, respectful, quality-focused work environment.

•       Additional Clinical Operations activities may be assigned as appropriate.

•       Travel as required to carry out responsibilities (up to 20%).

Bachelor's degree or equivalent training and experience (i.e., RN/PA, BSN degree)

Minimum 4-6 years of clinical study experience

•       Experience supporting global studies in a fast-paced environment

•       Success in working with CROs and vendors

•       Excellent communication skills and ability to achieve milestones in a team environment

•       Ability to communicate and collaborate respectfully in a remote environment

•       Experience working within a biotechnology or pharmaceutical sponsor organization

•       Prior experience as a monitoring Clinical Research Associate, including site initiation, interim monitoring, and close-out visits

•       Experience maintaining or overseeing Trial Master Files, including document completeness, quality, timeliness, and inspection readiness

•       Working knowledge of ICH E6(R3) Good Clinical Practice principles and risk-based quality management

•       Experience using M.S. Office Suite (Excel, Word, PowerPoint) and SmartSheet