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Form of workRegional Director
DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for a Regional Director to join our team.
The Regional Director will provide leadership, project management, and oversight for multiple locations, to plan and conduct clinical trials concurrently in accordance with the Sponsor goals; Standard Operating Procedures (SOPs); Good Clinical Practices (GCP), and regulatory guidelines. To plan, execute and meet organizational productivity goal.
Duties & Responsibilities:
- Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
- Managing and supervising the clinical and administrative staff, assuring that each clinical trial meets enrollment targets and is conducted in accordance with the clinical protocol(s) as approved by the Sponsor, all regulatory organizations, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory guidelines.
- Identify potential areas of risk, set priorities for internal reviews, site monitoring (of investigative sites ), and review, and approve corrective actions needed.
- Create risk mitigation strategies.
- Coordinating and collaborating with the various cross functional departments e.g. Clinical Operations, Recruitment, Human Resources, Central Services, to identify strategies for improved subject outcomes, site operating efficiencies, optimum subject experience, and risk assessment action plans.
- Identifying areas for improvement and developing detailed process flows, policies, and procedures to ensure consistent quality data is collected across DM Clinical Research sites.
- Directing and managing clinical operations personnel, including hiring, performance reviews, and termination.
- Monitoring and reporting protocol performance, timelines, and financial metrics on an ongoing basis to the management team, including the current status of the protocol.
- Any other matters as assigned by management.
Knowledge & Experience:
Education:
- Bachelor’s Degree; in a field of Medicine, Science, Behavioral Science, Nursing, or related field required
- Masters degree preferred
Experience:
- 5-7 years experience in a managing high growth clinical research sites required
- Multi study management required
- Team management required
- CNS clinical trial experience required
Credentials:
- ACRP- PM, ACRP-CP or equivalent preferred
Knowledge and Skills:
- Tenacity
- Goal Driven
- Solution Oriented
- 50% of travel required
