Site Director
Raleigh, WV - USA
Job Summary
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 operationsfrom 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 :
- Bachelors 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.
Additional Information :
About M3:
M3 USA is at the forefront of healthcare innovation offering digital solutions across healthcare life sciences pharmaceuticals and more. Since our inception in 2000 weve seen remarkable growth fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally facilitating impactful medical education precise job placement and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
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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Remote Work :
No
Employment Type :
Full-time
About Company
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, weve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficien ... View more