Clinical Research Site Manager

Overview
We are seeking a dedicated and experienced Clinical Research Site Manager to work onsite at our Lima, OH location. The Clinical Research Site Manager will oversee the management of clinical trials at our research facility. The ideal candidate will have a strong background in clinical research, excellent supervisory skills, and a thorough understanding of FDA regulations and Good Clinical Practice (GCP). This role is essential in ensuring the successful execution of clinical trials while maintaining compliance with all regulatory requirements, play a key role in driving site growth, staff development, and sponsor satisfaction.

Duties

• Oversee day-to-day site operations and ensure studies are conducted per protocol, GCP, and regulatory requirements.
• Supervise and mentor Clinical Research Coordinators, Regulatory Specialists, and support staff.
• Coordinate cross-functional activities across recruiting, scheduling, source documentation, and data entry to maintain timelines.
• Collaborate with PIs, sub-investigators, and sponsors to ensure study milestones are achieved.
• Monitor key site metrics (screening, randomization, query resolution, data entry timeliness, retention).
• Manage site budgets, invoicing, and sponsor payments with support from finance and leadership.
• Support feasibility assessments, pre-site selection visits, and business development initiatives.
• Develop and refine SOPs and workflows to improve efficiency and compliance.
• Serve as point of contact for sponsor/CRO monitors and auditors.

Qualifications

• Minimum 3–5 years of clinical research experience, including 1–2 years in a leadership or management role (Site Manager, Lead CRC, or equivalent).
• Proven experience in supervising clinical research teams or managing clinical trials.
• Strong knowledge of medical terminology, FDA regulations, GCP, and compliance management practices.
• Experience in data management, including familiarity with EMR systems and statistical software.
• Excellent analytical skills with the ability to interpret complex data sets effectively.
• Demonstrated ability to monitor patients effectively throughout the trial process.
• Familiarity with documentation review processes and adherence to regulatory standards in clinical research. Join our team as a Clinical Research Site Manager where you will play a crucial role in advancing medical research while ensuring the highest standards of patient care and compliance are met.
• Bachelor’s degree in health sciences, nursing, or related field (advanced degree preferred).
• Background in nursing or related healthcare field is preferred, along with clinical laboratory experience.
• Excellent organizational, leadership, and communication skills.
• Ability to manage multiple studies and teams in a fast-paced environment.
• Experience with CTMS, eSource, and eRegulatory systems preferred.
• CCRP, CCRA, or ACRP certification a plus.

Compensation

• Base Salary: $70,000 – $80,000 per year (commensurate with experience)
• Performance Bonus: Quarterly incentive based on measurable site metrics including:
• Patient enrollment and retention goals
• Timely data entry and query resolution
• Study close-out and audit readiness

Benefits

• Paid Time Off (PTO) and paid holidays
• Health, dental, and vision insurance (employer contribution)
• 401(k) retirement plan with employer match
• Tuition reimbursement and professional development support
• Opportunity for advancement to Director of Site Operations with expanded responsibilities

Why Join NexGen Research

• Physician-led organization with direct involvement in clinical and operational decisions
• Collaborative, growth-oriented culture
• Exposure to diverse therapeutic areas and sponsors
• Opportunity to shape a fast-scaling research network and lead future site expansions

Job Type: Full-time

Base Pay: $70,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person