Clinical Research Site Manager

M3USA•Raleigh, NC

12h•Onsite

About The Position

The Clinical Research Site Manager will work closely with leadership to provide oversight for all clinical trial activities at the site. This role is responsible for ensuring study execution, participant safety, regulatory compliance, data quality, and achievement of site performance goals. The Site Manager works closely with the Principal Investigator (PI), Regional Director, sponsors, CROs, and cross-functional teams to drive operational excellence and successful study outcomes.

Requirements

Bachelor's degree or equivalent and relevant formal academic experience.
5+ years of relevant experience as a clinical research associate or clinical research coordinator is required.
Must have experience managing trials.
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
Strong written and verbal communication skills.
An ability to consume, absorb, and analyze large amounts of information.
Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
Strong computer skills in appropriate software and related company clinical systems are required

Nice To Haves

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.

Responsibilities

Oversee daily site operations and ensure compliance with study protocols, GCP, ICH guidelines, and company SOPs.
Manage all phases of clinical trial execution, including study start-up, enrollment, conduct, and close-out.
Lead site feasibility assessments and support pre-study qualification visits with sponsors and CROs.
Partner with the Regional Director to manage site financial performance, including budget review, resource allocation, and cost management.
Collaborate with Business Development on new study opportunities, start-up timelines, and enrollment forecasting.
Supervise, mentor, and develop clinical and administrative staff, fostering a collaborative and high-performing team environment.
Oversee participant scheduling, site workflow, and resource utilization to support efficient operations.
Monitor key performance indicators (KPIs) and implement strategies to drive study success and operational excellence.
Review monitoring visit reports and ensure timely implementation of corrective and preventive actions (CAPAs) when required.
Serve as the primary operational contact for sponsors, monitors, CROs, and internal leadership.
Ensure timely and accurate source documentation, EDC data entry, and query resolution.
Support the PI and study team in maintaining participant safety, protocol compliance, and data integrity.
Lead study team meetings, site initiation visits, and cross-functional operational discussions.
Partner with Quality and Compliance teams to prepare for sponsor audits and regulatory inspections.
Identify operational gaps and lead continuous improvement initiatives to enhance site performance.
Mentor and train new investigators on company processes, SOPs, and organizational standards.
Collaborate effectively with multidisciplinary teams across the organization.
Plan and participate in community outreach and recruitment initiatives to increase site visibility and participant enrollment.