Senior Research Compliance Manager

Job Posted: March 09, 2015

Job Type: Professional

Job Location: Harvard/HSCRB/HSCI

Reporting to HSCRB Associate Director for Research Policy and Compliance, the Senior Research Compliance Manager plays a key role in both HSCRB Department and the Harvard Stem Cell Institute (HSCI) iPS (induced pluripotent stem cell) Core Facility supporting faculty compliance with human subjects and stem cell policies as well as managing the banking and distribution of human embryonic stem cell (hESC) lines and induced pluripotent stem cell (iPSC) lines in the iPS Core Facility.

Responsibilities 

  • Independently plan, organize, and manage IRB and ESCRO protocols for HSCRB faculty principal investigators (PIs) and iPS Core. 
  • Directly supervise Research Compliance Coordinator. 
  • Plan, organize and implement administrative systems/procedures for supporting PIs and department compliance with human subjects and stem cell policies. 
  • Serve as source of information on established guidelines, policies, and law and advise faculty, students, and/or staff appropriately. 
  • Communicate/negotiate with staff members, including central administration (IRB and ESCRO), HSCRB administrators, and Office of General Counsel (OGC) lawyers. 
  • Review pre-submission funding proposals for compliance with established human subject protocols; analyze and identify areas needing resolution and collaborate with staff to obtain timely assurances to secure funds. 
  • Collect, organize, and manage provenance information for HSCRB derived pluripotent stem cell lines. Act as primary resource on provenance and allowable use of each line to faculty, students and staff within HSCRB and in University community. 
  • Plan, organize, and implement standard operating procedures, policies, and processes for core facility. 
  • Support compliance aspects of research collaborations with outside institutions. 
  • Negotiate service agreements with requesting institutions when necessary, or coordinate with OGC/Office of Technology Development (OTD) to negotiate as appropriate. 
  • Oversight of deposit and distribution of iPS and hES lines from Core. Navigate and facilitate transition of banking and distribution of hPS lines to other banks. 
  • Support compliance and regulatory aspects of adding new services to Core, as appropriate.

Basic Qualifications 

BA/BS and work experience with human subjects research are required

Additional Qualifications

Advanced degree in relevant field (biology, nursing, public health, research administration, etc.) is preferred, depending on overall background. Five years of work experience managing human subjects research is required; solid understanding of federal and state laws and regulations governing human subjects research and human tissue banking and demonstrated experience writing IRB and/or ESCRO applications and renewals. Direct experience with human tissue banking, familiarity with Harvard processes and procedures, and supervisory experience are a plus. Experience working with multiple internal and external constituencies in setting agendas and implementing policies in a large decentralized institution. Proactive, time-sensitive, results driven approach to carrying out assigned and assumed responsibilities and possess the ability to handle multiple, often competing tasks with grace and good humor to achieve group goals. Ability to work independently, with minimal supervision and handle complex and confidential information with discretion. Excellent writing and communications skills are required. Proficiency with Microsoft Office applications; expert-level proficiency in Word required and competency with other Office applications (Outlook, Excel, Access, Adobe Acrobat Professional.)

Apply to this position here