Clinical Research Director - Saint Paul

On Time Talent Solutions; Saint Paul (MN); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

On Time Talent Solutions is seeking a Clinical Research Director to oversee, lead, and manage cross-functional teams and external service providers. Based in St. Paul, MN.

You will develop strategic plans, SOPs, and quality plans for clinical research, ensure regulatory compliance (FDA/IRB/HIPAA), and supervise managers across the Nemours enterprise. This role requires a Bachelor's degree, RN licensure, and 5+ years of leadership in clinical research, with strong collaboration and

Qualifications

• Bachelor's degree required; Master's preferred.
• 5+ years supervising clinical research teams.
• RN required.
• Familiarity with INDs and IDEs.
• Experience with HIPAA, FDA regulations, IRB requirements and GCP.

Responsabilités

• Develop clinical research strategic plans and objectives with research leadership.
• Develop SOPs and quality plans for clinical research across sites.
• Ensure federal regulations are followed; serve as SME for IND/IDE submissions.
• Track, report, and review study quality metrics; manage external vendors.
• Train trial teams; drive site selection and patient recruitment; monitor sites.
• Ensure trials are audit ready at all times.

Connaissances

RN

Team supervision

Regulatory knowledge

IND/IDE familiarity

HIPAA compliance

Budget management

Cross-functional collab

Formation

Bachelor's degree

Master's degree

Description du poste

St. Paul is the second city that forms Minnesota’s Twin Cities. As a large business hub in the upper Midwest, the St. Paul area is home to headquarters of many healthcare giants including Mayo Clinic, Ecolab, Allina and Essentia Health. Whether you are looking to relocate or are a current resident, job opportunities in St. Paul are abundant

On Time Talent Solutions is seeking a Clinical Research Director interested in overseeing, leading, and managing cross-functional team resources and external service providers.

Clinical Research Director Responsibilities:

• Work with research leadership to develop clinical research strategic plans and objectives
• Help develop best practices, methods, techniques, and operational standards for clinical research coordination at Nemours
• Collaborate with Quality Assurance to develop quality plans for the conduct of clinical trials at Nemours
• Develop, update, and maintain SOP’s for clinical research across all sites
• Ensure federal regulations are followed and serve as subject matter expert for the submission of IND’s, and IDE’s at Nemours
• Track, report, and review study quality metrics and identifies activities warranted to meet trial goals and timelines
• Supervise clinical research core managers and leads across the Nemours enterprise
• Write, prepare, and/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical documents
• Identify, qualify, audit, and manage all external vendors.. Take initiative to continually monitor each external vendor in performance management, elevate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives.
• Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.
• Responsible for ensuring the trial is “audit ready” at all times.

Clinical Research Director Qualifications:

• Bachelor's degree required; Master's degree preferred
• 5+ years supervising clinical research teams
• RN Required
• Familiarity with IND’s and IDE’s
• Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices
• Ability to Work collaboratively with cross functional internal groups/teams
• Ability to create and manage internal and external budgets for research protocols
• Experience with developing systems to manage/track productivity of clinical research functions