Site Director

M3USA

$100K — $120K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent experience, with CCRC or CCRA certification preferred.
  • Required prior experience as a Clinical Research Site Manager or Site Director.
  • Preferred 5+ years of clinical research experience.
  • Strongly preferred 3-5 years of people management experience.
  • In-depth knowledge of FDA regulations, ICH-GCP, and ISO standards; excellent organizational and problem-solving skills.
  • Strong written and verbal communication skills for analyzing complex information.
  • Ability to multitask effectively under tight deadlines in a team environment.

Responsibilities

  • Lead all clinical trial site operations from pre-study assessments to study close-out.
  • Hire, train, and develop site staff; set KPIs for operational excellence.
  • Manage enrollment and retention targets; implement strategies to minimize no-shows.
  • Oversee regulatory compliance and site readiness for inspections and audits.
  • Act as the primary liaison between the site, sponsors, and corporate teams; manage financial performance.
  • Coordinate site operations schedule to meet subject visit needs and work with Central Service teams.
  • Ensure staff maintain current training in FDA regulations and GCP; monitor protocol adherence.

Benefits

  • 401(k) plan with company matching contributions.
  • Comprehensive dental and health insurance options.
  • Disability and life insurance coverage.
  • Employee assistance program for personal and professional support.
  • Flexible spending account for healthcare needs.
  • Generous paid time off policy.
  • Vision insurance for eye health and wellness.
Full Job Description
Due to our continued growth, we are hiring for a Site Director at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC.

Job Description

Wake Research is a leading clinical research organization dedicated to advancing medical innovation through rigorous, high-quality clinical trials. The Clinical Research Site Director oversees all site operations to ensure the timely and compliant execution of assigned studies while maintaining the highest standards of quality and regulatory compliance. In this role, the Site Director advances that mission by leading day-to-day site operations and staff performance to consistently meet enrollment, quality, and compliance targets.

Including, but not limited to the following:
  • Lead all aspects of clinical trial site operations-from pre-study assessments and site initiation through subject recruitment, retention, and protocol compliance to study close-out
  • Hire, train, and develop site staff; conduct performance reviews and establish KPIs to ensure consistent operational excellence
  • Manage site enrollment and subject retention targets; implement strategies to reduce no-shows and meet protocol timelines
  • Oversee regulatory compliance, FDA/ICH-GCP adherence, and sponsor/CRO audit readiness; prepare site for monitoring and inspection visits
  • Serve as primary liaison between the site, sponsors, CROs, and corporate teams; manage budgets, revenue targets, and financial performance
  • Schedule site operations and staff coverage to meet subject visit needs; coordinate with Central Service teams (Source, CTMS, Regulatory, Quality, Marketing)
  • Ensure staff maintain current FDA and ICH-GCP training; monitor protocol adherence and source documentation quality
  • Evaluate trial viability and site capacity; work with business development to assess new trial opportunities and staffing requirements


Qualifications
  • Bachelor's degree or equivalent and relevant formal academic experience. Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), or equivalent certification, preferred.
  • Previous experience as a Clinical Research Site Manager or Site Director required.
  • 5+ years of clinical research experience preferred.
  • 3-5 years of people management experience strongly preferred.
  • 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; ability to consume, absorb, and analyze large amounts of information.
  • Ability to multi-task, work under time constraints, and work independently and cooperatively with interdisciplinary teams.


Benefits:

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
  • 401(k), 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

*M3 reserves the right to change this job description to meet the business needs of the organization

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