Compliance Manager

Location
Saint Louis, Missouri
Posted
Apr 16, 2019
Institution Type
Four-Year Institution

Compliance Manager

 

Office of Research Administration

This position’s primary responsibility will be managing and implementing all aspects of compliance administration on campus.  This includes research activity that involves humans (IRB) or animals (IACUC) as subjects to ensure compliance with federally mandated regulations protecting the rights and welfare of research subjects, conflict of interest (COI) and commitment (COC), export controls, and invention reporting to the government. This position will also manage docketing of patent and copyright related information and deadlines. The Compliance Manager will also orient new faculty, staff and students regarding compliance policies and procedures.

Responsibilities

Institutional Review Board (IRB), Institutional Animal Care and Use Committee

The Compliance Manager will monitor research activity that involves humans and/or animals as subjects to ensure compliance with federally mandated regulations protecting the rights and welfare of these subjects. Duties will include:

  • Provide administrative and technical support to Institutional Review Board and Institutional Animal Care and Use activities.
  • Review new applications for category of review, completion and potential problems.
  • Assign reviewer, monitor/support reviewer for completion of review.
  • Resolve problem applications with reviewer and investigator (this requires in-depth knowledge of the federal regulations and university policy); refer unresolved problems to the director.
  • Set the meeting agenda.
  • Attend and assist at meetings, including recording substantive changes to consent or application.
  • Initiate approval process for full Board or Committee and expedited projects including forwarding consents, requiring change, notifying investigators of additional Board requirements, review final consents and responses from investigators, generate approval letter and complete database entry.
  • Monitor continuing (annual) review process; support reviewer and investigator for completion of the review.
  • Provide support for the implementation of the eCompliance submission process.
  • Maintain database and create reports from the database.
  • Serve as ex-officio member to the Institutional Review Board (IRB) and provide regulatory expertise to the IRB in advising of compliance to federal regulations overseeing the rights and welfare of human research subjects.
  • Serve as ex-officio member to the Institutional Animal Care and Use Committee (IACUC) and provide regulatory expertise to the IACUC in advising of compliance to federal regulations overseeing the rights and welfare of animal research subjects.
  • Counsel investigators on the legal and regulatory aspects of human subjects' research; meet with research investigators and provide guidance on regulations for areas such as informed consent, investigational drugs and devices, and application procedures.
  • Monitor developments in case law and legislation in order to communicate with members of the IRB, the IACUC and researchers submitting research proposals involving humans or animals as subjects regarding current regulatory and administrative compliance. Provide regulatory expertise to the IRB, the IACUC, and administrative staff in grants and contracts to ensure that any new state or federal regulations are brought to the attention of the Board, the Committee and staff.
  • Act as central contact point for audits by regulatory agencies; provide campus liaison with representative agencies.
  • In concert with Board Chair and the Committee Chair, make recommendations for Board appointments and Committee appointments to the Vice Provost for Research and provide input regarding Board and Committee members' performance.
  • Interface with other relevant administrative and research units.
  • Provide a resource to office support staff in the processing of research proposal requests, and federal and state reporting requirements, and general office duties.
  • Demonstrate user computer skills and support for the implementation of the eCompliance submission process.
  • Update, maintain, and monitor the electronic IRB database and the IACUC database.
  • Create IRB reports from the electronic database as requested.
  • Work with office support staff in the processing of research proposal requests and general office duties.

Conflict of Interest

Manage the campus-wide conflict of interest (COI) and conflict of commitment (COC) program.

  • Manage and coordinate review activities for the campus’ Conflict of Interest Committee, COI/COC subcommittees, and COI/COC Oversight Committees.
  • Oversee and facilitate the implementation of MU’s internal COI/COC reporting and processing system, “eCompliance,” on the UMSL campus.
  • Support compliance aspects of UMSL faculty and staff entrepreneurial activities.
  • Coordinate initial review and routing as appropriate of submitted forms and related projects.
  • Review all new applications for category of review and potential problems.
  • Assign reviewer, monitor/support reviewer for completion of review.
  • Resolve problem applications with reviewer and investigator (this requires in-depth knowledge of the federal regulations and university policy); refer unresolved problems to supervisor.
  • Set the meeting agenda; attend and assist at meetings, including recording of minutes.
  • Review amendments. Forward to Chair as appropriate for signature.
  • Monitor continuing (annual) review process; support reviewer for completion of the review.
  • Monitor developing federal legislation and other external regulations, and communicate as necessary with administration and investigators on such issues.
  • Develop and implement procedures based on university and regulatory requirements, and act as central contact point/campus liaison for agency representatives
  • Communicate with General Counsel and other administrative and academic units regarding COI-related compliance needs.
  • Engage with other campus committees, such as the Institutional Review Board, regarding COI.
  • Orient new faculty, staff and students regarding compliance policies and procedures.

Export Controls

The Compliance Manager is responsible for support and coordination of the export compliance program for the University of Missouri–St. Louis campus. This includes but is not limited to:

  • Funding award contract support and review in conjunction with the grants and contracts administrators.
  • Identification of areas of export compliance risk and addressing those in conjunction with supervisor and faculty.
  • Recommendation of new and implementation of approved export compliance policies and procedures.
  • Development, implementation and audit of technology control plans for research projects.
  • Review of and support for physical shipments or other physical exchanges being made subsequent to a Material Transfer Agreement (MTA).
  • Review of visa certifications.
  • Monitoring of regulatory changes, issues and university best practices making recommendations as appropriate.
  • Educational development and programming.

Agreements

The Compliance Manager will manage the agreement term compliance function of all active license agreements, non-disclosure agreements, material transfer agreements, industry sponsored research agreements and others for UMSL. In collaboration with the UM System Office of IP Administration, this person will review and interpret terms of license agreements and work with licensees to ensure that the licensees are in compliance with both the financial and non-financial terms of the agreements, along with other related matters. Regarding license agreements, duties will include:

  • Diligently track performance obligations for all active agreements.  Generate various reports of licensee obligations to report due diligence in product development, milestone achievements related to clinical trials, financing activities of the organizations, reports of first sale, periodic reporting of licensed product sales and payment of royalties, meeting payment plan and convertible note obligations.  Initiate contact with licensees who do not meet and submit required reports according to the terms of the license agreements and work with the licensees to bring their agreements into compliance.
  • After execution, work with UM System Office of IP Administration to ensure agreement terms and billing and reporting criteria are logged.  Establish appropriate follow-up routines for future event driven term due dates. 
  • Invoice licensees for all non-financial terms, such as annual progress reports, review those reports for compliance with the license.
  • Review sales reports from licensees for accuracy and reasonableness.  Review public information (licensee websites, for example) for licensee milestone-related information and information that would assist in evaluating the reasonableness of reported sales by companies. Work closely with the licensing/business development staff to interpret this information in order for licensing staff to determine appropriate steps to take when a licensee may be in breach of contract. 
  • Manage and facilitate invoicing and distributing license revenue and assist with the administrative side of these compliance responsibilities.
  • Represents UMSL to companies. Must have good diplomacy.
  • Must have strong analytical skills and be able to convey information clearly both verbally and written.

Invention Reporting

Report federally funded inventions to the appropriate federal agency via the iEdison portal including patent applications and annual commercialization reports.

Other duties as assigned.

Minimum Qualifications
Bachelor’s degree or an equivalent combination of education and experience and at least three years of experience from which comparable knowledge and skills can be acquired is necessary.

Preferred Qualifications
Possesses expanded conceptual knowledge of legal and compliance function and broadens capabilities.

Salary Range: $47,476-$65,468 annually
Application Deadline: May 7, 2019

Application Instructions
Applicants must combine all application materials (cover letter, resume, and list of three references with contact information) into one PDF or Microsoft Word document and upload as a resume attachment. Limit document name to 50 characters. Maximum size limit is 11MB. Do not include special characters (e.g., /, &, %, etc.).

Please visit www.umsl.jobs and search Job ID 29867 to apply.

For questions about how applicants apply, please call (314) 516-5805, or if you are experiencing technical problems, please email [email protected]

Benefit Summary
The University of Missouri, St. Louis offers benefit-eligible employees a wide variety of benefits including; health, dental and vision coverage effective on the first day of employment, vacation & sick time accrual, four personal days per year, tuition assistance for employees and their dependents, pension and employee & dependent life insurance. For more information about our benefit, please visit http://www.umsystem.edu/totalrewards/benefits

UMSL is an equal access, equal opportunity, affirmative action employer that is fully committed to achieving a diverse faculty and staff. Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, sexual orientation, gender identity, gender expression, age, genetic information, disability, or protected veteran status.  

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