Research Regulatory Specialist

Position Description:

Every day, in ways both big and small, the Medical College of Wisconsin (MCW) is impacting lives for the better. MCW … changemaking for a healthier Wisconsin. In the role of a  Research Regulatory Specialist  you will beworking in the Cancer Center.  

Purpose

Member of the Cancer Center CTO Regulatory team responsible for gathering regulatory documents, preparing IRB applications, amendments and continuing review for human subject research ensuring compliance with Federal, State and Institutional Standard Operating Procedures. This CTO Research Regulatory Specialist will function as the regulatory liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the Cancer Center CTO’s goals.

Primary Functions

1.

Provide main administrative support for the preparation of multiple Internal Review Board (IRB) documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents. Following IRB guidelines, draft and/or modify documents as required by research program activities.

2.

Prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments and continuing progress reports. Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission.

3.

Support faculty with Investigator-Initiated IND/IDE applications; maintain IRB and FDA regulatory files for each IND/IDE and ensure routine monitoring is conducted as required.

4.

Facilitate study start up activities, as necessary, including submissions to Scientific Review Committee (SRC), Data Safety Monitoring Board (DSMB), Institutional Biosafety/Radiation Safety Committee, and ClinicalTrials.gov postings. 

5.

Work closely with CTO Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs associated with each assigned protocol.

6.

Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators.

7.

Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures.

8.

Collaborate with investigators and CTO Research nurses/study coordinators on the development of program materials including educational materials, marketing materials, websites, forms, and reports.

9.

Maintain program timeline including tracking deadlines for program components. Utilize MCW’s Clinical Trial Management System (CTMS) OnCore and Florence e’binder software to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.

10.

Coordinate notifications to all study team members regarding annual regulatory education requirements.

11.

Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program.

Knowledge – Skills – Abilities

Excellent oral and written communication skills are essential.  Strong critical thinking, problem solving and attentiveness to detail required. Additional training in regulatory compliance strongly preferred.

Preferred Schedule:

Fulltime 8-4:30

Position Requirements:

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education:               Bachelor’s degree.  

Minimum Required Experience:              2 years in compliance or healthcare field.  

Preferred Education:                              Bachelor’s Degree

Preferred Experience:                            Minimum 2 years clinical research regulatory support

Field:                                                    Sciences or compliance, clinical research

Certification:                                          CITI certification required within 30 days of hire. SoCRA and/or ACRP certification preferred.

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Pet Insurance
• On campus Fitness Facility, offering onsite classes.
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a full list of positions see: www.mcw.edu/careers  

For a brief overview of our benefits see: https://www.mcw.edu/departments/human-resources/benefits

Eastern Wisconsin is a vibrant, diverse metropolitan area.  MCW is intent on attracting, developing, and retaining a diverse workforce and faculty body that reflects the community we serve. We value diversity of backgrounds, experience, thought, and perspectives to advance excellence in science and medicine.  MCW is a welcoming campus community with a strong culture of collaboration, partnership, and engagement with our surrounding community. For more information, please visit our institutional website at https://www.mcw.edu/departments/office-of-diversity-and-inclusion . 

MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination

The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering a diverse community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual’s race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.

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