Site Operations Management
Assist with daily site activities acting as the primary point of contact for the site, ensuring appropriate staffing, training, and adherence to SOPs. Maintain compliant facilities and equipment.
Leadership & Staff Development: Assist with training and mentoring research staff. Uphold professional development goals and foster a culture of accountability, integrity, and continuous improvement.
Work with Manager, Operational Excellence to ensure high staff morale and low turnover rates
Regulatory & Compliance Oversight: Promote strict adherence to ICH-GCP, FDA, and local regulations, while maintaining audit readiness across all studies.
Assist Manager, Operational Excellence, Operational Compliance, and Quality Assurance Departments with all Care Quality and FDA audits
Business Development: Support feasibility assessments through partnership with Manager, Operational Excellence to ensure timely responses to questionnaires, and scheduling of site qualification visits.
Study Start-Up & Enrollment Oversight: Support with regulatory packet submissions, and site initiation processes. Work with investigators to meet or exceed patient recruitment and retention goals.
Assist with additional projects such as quality improvement initiatives, internal data monitoring ensuring accuracy, integrity, and timely entry of study data, and may represent the site at meetings and industry events.

A minimum of 5 years of clinical research experience, with at least 1-2 years in a supervisory or management role. CRC experience a plus.
Hands-on knowledge of ICH-GCP, FDA regulations, and local regulatory requirements.
Demonstrated success in study management, study start-up, patient recruitment, and compliance oversight.
Budget management, business development, or sponsor/CRO engagement experience is a strong plus.

Senior Associate, Operational Excellence

Key skills