JOB SUMMARY:

The Site Manager in Training (SMIT) is an entry-level leadership position designed to prepare individuals for future site management responsibilities. This role provides a structured development path that combines hands-on clinical operations exposure with training in regulatory compliance, staff oversight, and study execution. Under the guidance of site leadership, the SMIT supports daily operations while progressively taking on more responsibilities aligned with the Site Manager role.

QUALIFICATIONS:

• Bachelor’s degree in life sciences, healthcare, or a related field preferred.
• 1–2 years of experience in clinical research (e.g., Clinical Research Coordinator or similar role).
• Basic understanding of clinical trial operations and regulatory guidelines.
• Strong communication and organizational skills, with the ability to manage multiple priorities and adapt to a fast-paced environment.
• Demonstrated interest in advancing to a leadership role within clinical research site operations.
• Familiarity with Microsoft Office and clinical trial systems preferred.

• Assist with the daily operations of the clinical site, including patient scheduling, visit coordination, data entry, and regulatory documentation under the supervision of site leadership.
• Work alongside CRCs, regulatory staff, and patient-facing teams to understand staffing needs, workflow, and team coordination. Begin developing basic supervisory and communication skills.
• Participate in the development and implementation of study-specific operational plans, including staffing, resource planning, and timelines.
• Observe and support all phases of clinical trials, from start-up through close-out, gaining familiarity with site responsibilities including study feasibility, subject recruitment, protocol adherence, and data quality.
• Support the review of regulatory documentation, study submissions, and audit readiness processes to ensure compliance with GCP and applicable regulations.
• Learn to oversee source documentation, data entry, and protocol compliance by shadowing senior team members and participating in documentation reviews.
• Assist with tracking and maintaining participant recruitment metrics, data reporting timelines, and study-related milestones.
• Serve as a secondary point of contact for sponsor, CRO, and monitor communications, escalating issues to the Site Manager or RSM as appropriate.
• Support new staff training efforts by observing onboarding activities and assisting with training documentation and scheduling.
• Attend sponsor and monitor meetings to gain exposure to external communication and sponsor expectations.
• Assist with the preparation and organization of essential documents, source templates, and site files.
• Participate in site team meetings and training sessions to develop leadership, operational, and regulatory knowledge.
• Begin learning aspects of site budgeting, billing, and financial tracking by supporting leadership with documentation, payment logs, and sponsor correspondence.
• Complete required training modules and competency assessments as part of the developmental track to Site Manager.
• Develop professional relationships with monitors, CROs, vendors, and internal stakeholders through observed and supervised interactions.
• Assist in tracking key performance indicators and site metrics under guidance from the Site Manager or Regional Site Manager.