Description
Lead the planning, execution, and oversight of clinical research programs, managing teams, timelines, budgets, and quality to meet protocol and regulatory requirements. Serve as the primary liaison with investigators, sponsors, CROs, and oversight bodies while driving data integrity, audit readiness, and operational excellence.
- • Build and maintain sponsor and partner relationships to secure new clinical trials.
- • Stay current with GCP, regulatory changes, and therapeutic advances; guide staff development.
- • Oversee patient registration with coordinating/statistical centers.
- • Lead audit readiness and host sponsor, IRB, and regulatory inspections.
- • Develop, track, and reconcile study and departmental budgets; approve disbursements.
- • Define and oversee protocol-specific clinical and procedural workflows.
- • Provide guidance on protocol interpretation, dosing rules, and treatment calculations in collaboration with PIs.
- • Approve and oversee subject recruitment strategies and materials, ensuring IRB approval.
- • Negotiate and manage vendors and technology to meet equipment and software needs.
- • Coordinate with clinical leaders to optimize recruitment and referral pathways.
- • Monitor enrollment, screen failures, and retention metrics; direct corrective actions.
- • Assess operational feasibility and risk for proposed protocols and data management plans.
- • Oversee safety management plans, adverse event capture, and timely regulatory reporting.
- • Ensure preparation, review, and submission of protocol documents, manuals, IRB packages, and progress reports.
- • Contribute to protocol, CRF, and SOP development and continuous process improvement.
- • Ensure compliant informed consent processes and periodic consent audits.
- • Oversee investigational product forecasting, ordering, storage, and accountability.
- • Plan and allocate space, supplies, and equipment for study operations.
- • Serve as primary contact for sponsors/CROs; schedule and coordinate site visits and responses.
- • Train, mentor, and evaluate research staff on standards of care, GCP, and documentation.
- • Ensure patient-facing communications are accurate, approved, and culturally appropriate.
- • Lead issue escalation, deviation management, and CAPA; implement protocol amendments.
- • Supervise biospecimen plans, chain-of-custody, and shipments to central labs.
- • Oversee follow-up data collection and outreach to external providers and subjects.
- • Manage laboratory partnerships, test ordering workflows, and reporting of results.
- • Support investigators with study reports, presentations, and publications.
- • Monitor data quality, query resolution, and timelines for data locks and analyses.
- • Supervise eligibility screening processes and confirmation by qualified personnel.
- • Plan site start-up activities, staffing models, and resource allocation across studies.
- • Implement scheduling systems to ensure on-time visits, procedures, and admissions.
- • Oversee compliance with protocols, SOPs, and all applicable regulations and institutional policies.
- • Ensure complete, accurate, and audit-ready regulatory binders and study records.
- • Maintain sponsor invoicing, milestone tracking, and financial reconciliation.
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
