Clinical Research Site Manager

Location: Raleigh/Durham, NC

Reports to: Regional Director of Operations

Position Summary

The Site Manager leads the day to day operations of a clinical research site. This role translates study commitments into reliable execution, supervises site staff, supports investigators, and ensures participants receive a safe, organized experience. The Site Manager owns site readiness, enrollment execution, documentation quality, and timely escalation of operational and compliance issues in partnership with regional and centralized teams.

Key Responsibilities

•Lead daily staffing, schedules, workload allocation, coverage, and site meetings; coach coordinators and other assigned staff and address performance issues promptly.

•Maintain study level activation and enrollment plans, including training, delegation, essential documents, supplies, investigational product readiness, and visit capacity before recruitment begins.

•Review recruitment funnels with central patient engagement and site staff; resolve prescreening, scheduling, no show, and screen failure bottlenecks while protecting participant privacy.

•Track visit completion, data entry, query aging, deviations, follow up, and closeout obligations; intervene early when timelines or quality are at risk.

•Partner with principal investigators and subinvestigators to maintain appropriate oversight, availability, delegation, protocol adherence, and timely review and signoff.

•Maintain inspection ready records and facilities under Eximia SOPs, GCP, protocols, IRB requirements, and applicable law; coordinate monitoring visits, audits, corrective actions, and training.

•Oversee site resources, vendor coordination, equipment maintenance, temperature monitoring, and escalation of facility or investigational product concerns.

•Coordinate with start up, regulatory, budgets and contracts, finance, business development, quality, and regional operations; provide accurate operational updates and raise barriers with proposed solutions.

•Monitor site labor and controllable expenses against plan, review study productivity and visit utilization, and support accurate capture of completed work for billing.

•Build relationships with practice partners, referral sources, and the local community consistent with approved outreach and privacy practices.

Qualifications

•Bachelor’s degree in a health or life science field preferred; equivalent clinical research experience considered.

•At least five years of clinical research site experience (CRC), including two years leading people or site operations, preferred.

•Working knowledge of ICH GCP, informed consent, protocol execution, source documentation, investigational product controls, and inspection readiness.

•Experience with CTMS, electronic regulatory systems, electronic source, and standard productivity reporting.

•Ability to prioritize across multiple studies, coach staff, communicate with investigators and sponsors, and resolve issues with sound judgment.

•Current ACRP or SOCRA certification preferred.

Measures of Success

•On time study activation and complete site readiness before first participant activity.

•Enrollment and retention performance against study plans, with timely corrective actions for gaps.

•Visit completion, data entry and query timeliness, low preventable deviation rates, and timely CAPA closure.

•Staff retention, training completion, appropriate coverage, and productive use of site capacity.

•Accurate site reporting and timely escalation of participant safety, quality, staffing, and facility risks.

Work Expectations

This is an onsite leadership role with occasional travel to other locations or investigator meetings. The employee must be able to work in a clinical environment and meet the essential duties of the position with or without reasonable accommodation.

Our Company is an equal opportunity employer. This description summarizes the role and may be updated as business needs evolve.