Responsibilities
- Oversee daily operations at the research site while ensuring adherence to study protocols, Good Clinical Practice (GCP), ICH guidelines, and internal standard operating procedures.
- Manage all stages of clinical trial execution, from study initiation and participant recruitment through trial conduct and site closeout.
- Lead assessments of site feasibility and assist in pre-study qualification visits with sponsors and contract research organizations.
- Work with regional leadership to monitor financial performance, including budget evaluation, staffing alignment, and expense control.
- Coordinate with business development teams to evaluate new study opportunities and project timelines, including enrollment projections.
- Supervise, guide, and support clinical and administrative personnel to build a collaborative and high-performing team culture.
- Oversee participant scheduling, workflow coordination, and efficient use of site resources to maintain smooth operations.
- Track key performance metrics and implement strategies to improve study outcomes and operational efficiency.
- Review reports from monitoring visits and ensure prompt follow-up on corrective and preventive actions when necessary.
- Act as the main point of contact for operational communication with sponsors, monitors, CROs, and internal stakeholders.
- Ensure accurate and timely source documentation, electronic data capture entry, and resolution of data queries.
- Support the principal investigator and study staff in maintaining participant safety, protocol adherence, and data quality.
- Lead team meetings, site initiation activities, and cross-functional discussions to align operational goals.
- Collaborate with quality assurance teams to prepare for sponsor audits and regulatory inspections.
- Identify inefficiencies in operations and lead initiatives to improve site performance and processes.
- Train and mentor new investigators on organizational procedures, SOPs, and compliance standards.
- Work effectively with diverse teams across departments and functions.
- Plan and engage in community outreach efforts to boost site visibility and increase participant recruitment.
