Position Summary

The Site Manager reports directly to the assigned Regional Site Manager and is responsible for the deployment, oversight, and maintenance of Elite Clinical Network (ECN) processes in the conduct of clinical trials. This role includes full accountability for all site staff and operations.

The Site Manager is responsible for the daily operational oversight and overall performance of a clinical research site. This role ensures that clinical trials are conducted efficiently, in compliance with regulatory requirements, and in alignment with company objectives. The Site Manager oversees site staff, coordinates resources, monitors key performance indicators, and fosters a high-performing, patient-centric research environment.

Roles and Responsibilities:

• Manage all aspects of study execution from initiation through close-out to ensure adherence to projected timelines, high-quality protocol execution, and full compliance with internal ECN processes.
• Monitor and manage site-level revenue and expenses, ensuring financial targets are achieved. Collaborate with finance and leadership to track study billing, manage budgets, review payment schedules, and control costs to maximize site profitability and financial health.
• Create and implement detailed operational plans tailored to each study, including staffing, equipment, resource needs, and timelines, ensuring effective resource allocation and protocol compliance.
• Ensure accurate and timely completion of all regulatory reporting in accordance with GCP, ICH guidelines, and applicable local, national, and international regulations. Maintain documentation and audit readiness at all times.
• Oversee data integrity through routine documentation review, source verification, and efficiency checks. Ensure accuracy, completeness, and compliance of all collected data with study protocols and regulatory expectations.
• Maintain accountability for timely and accurate data entry and reporting. Monitor submission timelines to ensure sponsor and regulatory deadlines are met without exception.
• Meet or exceed all participant recruitment and enrollment goals by implementing proactive recruitment strategies and monitoring enrollment performance.
• Serve as the primary point of contact for Sponsors, CROs, and vendors, ensuring timely communication, resolution of operational issues, and alignment on study deliverables.
• Provide comprehensive training and onboarding for new site staff, ensuring protocol requirements, regulatory guidelines, and site-specific procedures.
• Plan and lead regular site team meetings to foster communication, address operational challenges, share study updates, and ensure consistency across clinical and administrative functions.
• Collaborate closely with the Regional Site Manager and attend required leadership meetings to ensure alignment of study progress with organizational priorities and performance targets.
• Oversee the evaluation, selection, and performance management of research staff to ensure staffing adequacy, team competency, and support for study operations.
• Maintain and routinely audit the site’s master training file, including staff certifications, licensure, and training records, to ensure compliance and readiness for inspections.
• Develop and maintain collaborative relationships with monitors, project managers, vendors, and sponsor representatives, facilitating streamlined operations and issue resolution.
• Develop and maintain assigned source documentation in accordance with protocol specifications, ensuring data quality, consistency, and real-time updates throughout the study lifecycle.
• Review monitoring visit follow-up letters promptly, identify findings or recommendations, and implement/document corrective and preventive actions to maintain compliance and quality standards.
• Monitor site and clinic performance trends regularly, proactively identifying areas for improvement and implementing corrective strategies to drive operational efficiency and excellence.
• Cultivate and maintain a professional, respectful working relationship with all affiliated physicians, ensuring alignment of clinical responsibilities and fostering site-level collaboration.
• Identify and engage additional physicians when needed to support protocol-specific assessments or examinations, ensuring study timelines and requirements are consistently met.

Education and Experience

• Bachelor’s degree in a scientific or healthcare field
• Minimum of 5 years in clinical research management or other applicable management experience
• Minimum of 3-5 years in patient facing clinical research experience.

Knowledge and Skills Required

• Excellent written and verbal communication skills
• Advanced management skills with the ability to lead a team
• Ability to organize and manage multiple projects & priorities
• Commitment to the vision and mission of Elite Clinical Network
• Experience working with multiple IRBs, Sponsors/CROs, and vendors
• Extensive knowledge and mastery of Microsoft Office, RealTime CTMS, GCP and other industry standards
• Demonstrated ability to learn quickly and generate solutions to complex problems
• Ability to work independently, within a multi-disciplinary team, as well as with sponsors and vendors

Site Operations Expectations

• On-Site Presence: Site Managers are expected to be physically present at their assigned clinic Monday through Friday during standard operating hours, for a minimum of 8 hours per day and 40 hours per week.
• Time Off Protocol: If time off is needed, prior notification must be given to your Regional Site Manager. Approval should be obtained before it is taken.
• Coverage Responsibility: It is the Site Manager’s responsibility to ensure that all operational duties are adequately covered during any absence. This includes coordinating with appropriate team members to maintain seamless clinic operations.

Email Communication Protocol

• Timely Response Requirement: All emails must be reviewed and responded to within 24 hours of receipt to ensure timely communication and operational efficiency.
• Inclusion of Leadership: The Regional Site Manager (RSM) must be copied (CC’d) on all email correspondence related to site operations, clinical activities, or sponsor communications.

Sponsor and CRA Communication

• Site staff must inform all sponsor representatives, Clinical Research Associates (CRAs), and CRO contacts to include the Regional Site Manager on all future communications involving the site. This ensures transparency, accountability, and consistent oversight of study activities.