MANAGER-CLINICAL RESEARCH COORDINATION

General Responsibilities

To manage all aspects of research program and clinical studies including education/teaching.

To oversee and manage multiple clinical research protocols and the associated personnel.

To design best practices for management of IP for drug, device, and biologic studies.

To prepare study budgets.

To manage research staff within area including all applicable human resources functions.

Key Duties & Responsibilities

• Provides leadership and operational oversight for a complex clinical research program involving multiple clinical studies and research personnel.
• Serves as a key resource for faculty, sponsors, and research staff, ensuring studies are conducted in compliance with institutional, sponsor, federal, and regulatory requirements.
• In addition to managing study operations, this role is responsible for supervising and mentoring research staff, driving quality improvement initiatives, overseeing clinical trial management systems, and conducting quality assurance activities.

The Position

The position offers an opportunity to influence research operations, develop best practices, and contribute to the growth and success of the CCTU.

Qualifications

• Eight (8) years of related experience required.
• Bachelor's degree in a related field and eight (8) years of related experience required.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification strongly preferred.
• Preferences:
• Degree in Clinical Research, Public Health, etc.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification strongly preferred.

Hard Skills

• Experience managing clinical research operations, staff, and regulatory compliance in a complex academic medical center, healthcare, or research environment.
• Knowledge of FDA regulations, ICH-GCP guidelines, and human subject research protections.
• Experience managing multisite and/or industry-sponsored clinical trials.
• Experience with Clinical Trial Management Systems (CTMS), such as OnCore.
• Experience with Electronic Data Capture (EDC) systems
• Quality assurance, auditing, and regulatory compliance oversight.
• Research program development and process improvement.
• SOP development and implementation.
• Project management.
• Experience with institutional research systems such as IRAP and OnCore.

Soft Skills

• Leadership and staff development.
• Staff training and competency development.
• Coaching, mentoring, and training.
• Strategic thinking and problem-solving.
• Excellent organizational and prioritization skills.
• Strong written and verbal communication skills.
• Collaboration and relationship building with faculty, sponsors, and interdisciplinary teams.
• Conflict resolution and performance management.
• Ability to manage multiple competing priorities in a fast-paced environment.