Associate Regional Director

Associate Regional Director

The Associate Regional Director will provide leadership, project management, and oversight to plan and conduct clinical trials concurrently in accordance with the Sponsor, all regulatory organizations, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory guidelines as well as ensure productivity per the company's goals.

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 with the study team 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 being collected across DM Clinical Research sites.
• Working with senior leadership, including the Sponsor, Site Directors, and Clinical Operations staff, managing each trial's clinical and operational aspects, and allocating resources as needed.
• 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.
• Collaboration with cross-functional teams.
• Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor's degree required; advanced degree preferred.

Experience:

• 5 years as a CRC preferred.
• 3-4- years of supervisory experience leading a team of 5+ people

Credentials:

• Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.

Knowledge and Skills:

• Ability to multitask, adhere to deadlines, and work independently and cooperatively with interdisciplinary teams.
• Strong computer skills in relevant software and related clinical systems are required.
• Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP), and ISOs.
• Strong leadership skills
• Must be detailed-oriented, proactive, and able to take the initiative.
• Must have strong written and communication skills.
• Must have excellent customer service skills and strong analytical skills

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