Manager - Research Compliance - Detroit

📁
Business (Non-Clinical)
📅
2114916 Requisition #

GENERAL SUMMARY:

The Manager of Research Compliance (MRC) provides the oversight for all compliance areas in Research Administration: the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), the Institutional Recombinant DNA and Biosafety Committee (IRDBC), and other regulatory activities and operational procedures involved with the monitoring and compliance requirements of all external agencies. This includes the Food and Drug Administration (FDA), Good Clinical Practice (GCP), US Department of Health and Human Services, Office for Human Research Protection (OHRP), Office of Laboratory Animal Welfare (OLAW), Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Guidelines for Research Involving Recombinant or Synthetic Nucleic Molecules, all guidance for the hazardous material handling and shipping, biosafety, disinfection and sterilization, research involving recombinant DNA molecules, and all other relevant research guidance in both an animal, human subject and laboratory research environment. The MRC will also have the supervisory responsibilities for the staff in the above compliance areas. Reports to the Administrative Director of Research.

PRINCIPLE DUTIES AND RESPONSIBILITIES:

  • Accreditation and regulatory compliance: 
  • Coordinates throughout the research environment activities to ensure that the IRB, IACUC and IRDBC comply with all require guidance and regulations. 
  • Develops a consistent plan for complying with the following regulatory agencies: Food and Drug Administration (FDA), Good Clinical Practice (GCP), US Department of Health and Human Services, Office for Human Research Protection (OHRP) Office of Laboratory Animal Welfare (OLAW) Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) 
  • Reviews and revises policies and procedures to ensure that each area remains in compliance. 
  • Assesses staff compliance, trains and educates staff to ensure that they are knowledgeable in their area of responsibility. 
  • Trains and educates Principal Investigators, RNs, Coordinators, Grant Managers, etc. to ensure that they are knowledgeable and compliant with all regulations, policies and procedures. 
  • Develops education modules for departmental and System research staff. 
  • Serves as a resource for all departmental staff regarding compliance in their respective areas. 
  • Functions as a liaison for announced and unscheduled site visits, audits and surveys. 
  • Responsible for the investigation, interviewing of staff and the gathering of data to address regulatory agency requirements, and preparing the necessary reports, up to and including the development and implementation of corrective action plans.
  • Assists Research Administration leaders and staff to assure site and audit readiness.
  • Acts as the primary interface with regulatory agencies.
  • Maintains a Performance Improvement Dashboard to identify compliance initiatives and progress towards meeting the defined goals.
  • Manages employees in the IRB, IACUC and IRDBC areas.
  • Maintains a collaborative working relationship across the research continuum including the Chairs of the IRB, IACUC and IRDBC Committees.
  • Working knowledge of various databases with the ability to input data and run reports.
  • Assists the compliance areas with applications. This will involve application reviews and assisting staff with operations.
  • Serves as a liaison to internal and external individuals and professional groups to interpret procedures and policies and disseminate information.
  • Prepares a wide array of statistical and administrative reports and summaries skills.

EDUCATION/EXPERIENCE REQUIRED: 

  • Bachelor’s Degree in related field. Master’s Degree preferred.
  • Minimum of seven (7) years of experience in regulatory research compliance.
  • Strong organization skills the ability to work independently.
  • Personal and professional written and verbal communication skills.
  • Teambuilding skills.
  • Customer service values.
  • Leadership skills. 
  • Critical thinking and decision-making skills.

    Overview

       Under the leadership of President and CEO Wright L. Lassiter, III, Henry Ford Health System is a

       $6 billion integrated health system comprised of six hospitals, a health plan, and 250+ sites

       including medical centers, walk-in and urgent care clinics, pharmacy, eye care facilities and

       other healthcare retail. Established in 1915 by auto industry pioneer Henry Ford, the health system

       now has 32,000 employees and remains home to the 1,900-member Henry Ford Medical Group, one

       of the nation’s oldest physician groups. An additional 2,200 physicians are also affiliated with the

       health system through the Henry Ford Physician Network. Henry Ford is also one of the region’s  

       major academic medical centers, receiving between $90-$100 million in annual research funding and

       remaining Michigan’s fourth largest NIH-funded institution. Also an active participant in medical

       education and training, the health system has trained nearly 40% of physicians currently practicing

       in the state and also provides education and training for other health professionals including nurses,

       pharmacists, radiology and respiratory technicians. visit HenryFord.com.

     Benefits

       Whether it's offering a new medical option, helping you make healthier lifestyle choices or

       making the employee enrollment selection experience easier, it's all about choice.  Henry

       Ford Health System has a new approach for its employee benefits program - My Choice

       Rewards.  My Choice Rewards is a program as diverse as the people it serves.  There are

       dozens of options for all of our employees including compensation, benefits, work/life balance

       and learning - options that enhance your career and add value to your personal life.  As an

       employee you are provided access to Retirement Programs, an Employee Assistance Program

       (Henry Ford Enhanced), Tuition Reimbursement, Paid Time Off, Employee Health and Wellness,                 and a whole host of other benefits and services.  Employee's classified as contingent status are not         eligible for benefits.    

      Equal Employment Opportunity/Affirmative Action Employer

        Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health System is

        committed to the hiring, advancement and fair treatment of all individuals without regard to

        race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height,

        weight, marital status, family status, gender identity, sexual orientation, and genetic information,

        or any other protected status in accordance with applicable federal and state laws.

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