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POSITION SUMMARY:

Under the general direction of the Director, Clinical Research Operations or designee, the Associate Director, Clinical Research Compliance will provide day-to-day oversight and guidance of  UMass Chan Medical School.  CCTS clinical research compliance program, including but not limited to regulatory and accreditation oversight and the review, negotiation and conclusion of complex externally funded clinical trial and other agreements.

** This is a hybrid work model with the understanding that the Associate Director, Clinical Research Compliance will be available and onsite as required to support the department. **                                                 

ESSENTIAL FUNCTIONS:

• Responsible for the drafting, negotiating and managing of a wide variety of clinical research contracts in a timely manner, including but not limited to confidentiality, consulting, data use and clinical research agreements
• Oversee OCR contracting/compliance staff on the use of contract templates and identifying legal issues
• Assist in identifying, implementing and maintaining contract management tools and other technology related to the department
• Collaborate with other internal contracting departments when triaging agreements/contracts to facilitate appropriate review
• Responsible for managing and monitoring OCR clinical research compliance programs
• Assist with the identification, interpretation, implementation and maintenance of relevant federal and state regulations and local policies
• Investigate clinical research compliance concerns and develop recommendations for action
• Lead central OCR support staff to ensure compliance with various UMMS regulatory policies and procedures
• Represent OCR/CCTS in strategic planning initiatives
• Oversee the development, review and revision of applicable curriculum, training materials, job aids, SOPs, and policies
• Provide general advice, guidance and support to senior management and scientific teams
• Manage staff, make hiring decisions, provide coaching, training & mentoring, manage performance and determine staffing needs
• Responsible for CCTS/OCR metrics are captured in an accurate and timely manner
• Perform other duties as assigned.

REQUIRED QUALIFICATIONS:

• Master's Level Degree, or equivalent experience
• 5-10 years of experience drafting and negotiating contracts/agreements, and budgets related to biomedical/science industry.
• 2 or more years of management experience.
• Expert knowledge and understanding of federal, state regulations and guidance related to clinical research.
• Experience prioritizing multiple, ongoing initiatives.
• Strong computer and software skills.                                                                                                                                                

PREFERRED QUALIFICATIONS:

• Experience with developing and negotiating clinical trial budgets
• Prior experience in an academic health center or hospital; OnCore clinical trial management experience  
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