Senior Clinical Research Associate

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Clinical Research Associate to join a pharmaceutical company ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts. Main Job Tasks and Responsibilities: Site management and relationship • Serve as the primary sponsor/CRO contact for assigned sites, maintaining regular communication with Principal Investigators, sub-investigators, and study coordinators. • Track site performance against follow-up visit schedules, data entry timelines, and query resolution metrics; escalate risks early. • Support sites through staff turnover, including retraining of new personnel and updates to the delegation log. • Ensure sites maintain adequate resources, equipment calibration (e.g., PSG/HSAT devices, CPAP or study device logs where applicable), and storage of investigational product or devices. Monitoring and oversight • Conduct on-site, remote, and risk-based monitoring visits per the Clinical Monitoring Plan, and complete visit reports and follow-up letters within required timelines. • Perform source data verification (SDV) and source data review (SDR) of follow-up visit data, including sleep study results (AHI, ODI, oxygen saturation), questionnaires (e.g., Epworth Sleepiness Scale, FOSQ), and device adherence data. • Verify ongoing informed consent compliance, including re-consent following protocol or ICF amendments. • Review and confirm accurate reporting of adverse events, serious adverse events, and device deficiencies within regulatory timelines. • Identify, document, and follow up on protocol deviations, and ensure corrective and preventive actions (CAPAs) are implemented. • Oversee investigational product or device accountability, reconciliation, and return or destruction. Subject retention and follow-up • Work with sites to minimize missed visits and loss to follow-up, reviewing retention strategies and tracking visit windows. • Monitor early terminations and withdrawals, ensuring reasons are documented and follow-up data is collected where the protocol allows. • Ensure completion of all long-term and end-of-study follow-up assessments. Data quality and database lock • Drive timely resolution of data queries in the EDC system and support data cleaning activities. • Collaborate with Data Management on interim and final data reviews, and prepare sites for database lock. Regulatory and documentation • Ensure the Investigator Site File (ISF) is complete and reconciled with the Trial Master File (TMF). • Track IRB continuing reviews, amendment approvals, safety report submissions, and other required regulatory documents. • Prepare sites for sponsor audits and FDA inspections, and support responses to findings. Closeout and post-study support • Plan and conduct site closeout visits, including final IP/device reconciliation, document archiving instructions, and IRB closure notification. • Support post-study activities such as final reconciliation, close-out reports, and responses to post-lock data or regulatory requests. • Contribute to lessons learned and process improvements for the study team. Education and Experience: Required • Bachelor's degree in life sciences, nursing, pharmacy, or a related health field (or equivalent experience). • 2+ years of independent on-site monitoring experience as a CRA with a sponsor, CRO, or