Director – Clinical Research Administration

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General Responsibilities 

Excellent opportunity to join a unique Best in Class, High Quality and Healthier Healthcare services organization.  Operate with a high degree of independence to manage a portfolio of NIH, industry, and non-profit sponsored clinical research studies at multiple sites. Provides direction and development of approximately 4 to 10 direct reports & long-range plans for achieving program goals, processes and tools for reporting and productivity. Support clinical research in rheumatology, autoimmune, musculoskeletal, and inflammatory diseases, particularly focused on real-world evidence generation. Manages research program expenses and budget, networking/public relations, technical training and assistance, grant and progress report writing, and regulatory responsibilities. Exceptional interpersonal, organizational, and written/verbal communication skills are required, with attention to detail and experience managing complex clinical research activities.

Key Duties & Responsibilities

  1. Acts as a subject matter expert (SME) for faculty and staff regarding administrative duties for governmental, non-profit, industry and other sponsored clinical research.
  2. Supports principal investigator(s) in providing fiscal and regulatory oversight to research activities and project accounts.
  3. Manages and maintains the study’s compliance with institutional requirements.
  4. Manages, assesses and determines solutions for operational shortcomings of study protocols.
  5. Manages and determines operational elements needed for conduct of clinical studies, which may include prospective interventional studies (e.g. traditional and pragmatic trials), prospective observational studies and retrospective observational studies.
  6. Manages grants and legal contract submission process, including compiling/drafting grants and reports through the central administrative processes and legal review.
  7. Schedules/participates in weekly project, team, and lab meetings.
  8. Coordinates meetings/conferences with University offices & external agencies as needed to include coordinating travel arrangements for the PI/research team.
  9. Assists with creation and maintenance of study manuals of procedures as needed.
  10. Manages and assists colleagues in identifying efficiencies and improving process. Provides human resource oversight for subordinate personnel. Trains staff in various work responsibilities.
  11. Contributes to strategic planning. Presents on a variety of topics relative to the research program to convey knowledge as appropriate. Maintains currency in field through cross training, continuing education, literature and seminars in order to implement this knowledge.

Minimum Requirements

Bachelor’s degree in a related field and eight (8) years of related experience required.

Licenses / Certifications / Registrations

Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification desirable.

Knowledge / Skills / Abilities

  • Critical thinking skills
  • Problem-solving skills across a wide variety of clinical studies
  • Expert knowledge of related scientific and clinical terminology
  • Leadership & Presentation skills
  • Prioritization & Organizational skills
  • Process improvement and quality skills
  • Technical and medical writing skills

CITI IRB training will be required upon hire. Well-developed writing, communication, interpersonal, and organizational skills are required. Individual must be able to work independently and within a team environment. All duties will be conducted in accordance with federal guidelines for conduct of research with human subjects. The ideal candidate will have experience in clinical research management and/or comparative effectiveness research.

Location: Boca Raton, Florida – Remote Hybrid 3days a week Tuesday and Thursday in office

Salary: $95k to 120K 

Are you available?
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