M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
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 DescriptionWake 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
- 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.
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, we’ve 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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Skills Required
- Bachelor's degree or equivalent relevant formal academic experience
- Previous experience as a Clinical Research Site Manager or Site Director
- Knowledge of FDA regulations, ICH-GCP, and ISO standards
- Strong teamwork, organizational, interpersonal, attention-to-detail, and problem-solving skills
- Strong written and verbal communication skills
- Ability to analyze large amounts of information, multitask, work under time constraints, and work independently and collaboratively
- Certified Clinical Research Coordinator, Certified Clinical Research Associate, or equivalent certification
- 5 or more years of clinical research experience
- 3 to 5 years of people management experience
What We Do
M3 USA believes in growth, for our company and for the people who drive it's success. Founded with the goal of changing the world of medicine by leveraging the power of the internet, the M3 Group, of which M3 USA is a part, provides comprehensive, leading edge, digital services to the healthcare and life science industries. We reach over 2.5 million doctors through our physician websites across the US, Asia, and Europe. M3 offers a variety of proven ways to engage physicians and get important clinical and marketing messages to valued, targeted audiences. Our live programs are delivered by clinical educators who are credentialed healthcare professionals. They provide strategic solutions to address the gaps that occur in clinical practice in the management of chronic diseases while also improving access for sales representatives. Those solutions include disease state knowledge, appropriate patient diagnosis, adherence, best practices, treatment to guidelines and REMS programs. Our digital health information services that include: the most up-to-date daily, indexed clinical information/news; medical education; market research; ethical drug promotion; clinical development; job recruitment and clinic appointment services. M3 Inc. is a publicly traded company on the Tokyo Stock Exchange and is a global leader in digital solutions in healthcare and has acquired dozens of companies across the globe. M3 Inc has had consistent growth since inception in 2000, with over 500 million dollars in revenue. Our great success is due to the skills and the high performance of our people, and has helped us attract some of the world’s leading talent from the most respected universities and Fortune 100 companies.
