Research Regulatory Coordinator - Virtual

We’re looking for those individuals—the creative thinkers and innovation seekers—who are content with nothing short of changing the world. Discover the endless opportunities within the Medical College of Wisconsin (MCW) and be inspired by the work we can do together to improve health, and make a positive, daily impact in our communities. In the role ofa Research Regulatory Coordinator  you will beworking in our 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 Coordinator will function as a 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

• 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
• Working knowledge of e-Bridge, electronic IRB and Grants and Contracts functions.
• Working knowledge of OnCore (Clinical Trials Management software) and the Florence E’Binder System
• Work collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions and maintaining open communication.
• Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate training for program participants.
• Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants.
• Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Coordinate notifications to study team members regarding annual regulatory education requirements
• Coordinate program outreach activities including acting as a liaison with community organizations, providing regulatory support for the Cancer Centers at Froedtert Menomonee Falls, Froedtert West Bend, Drexel Town Square Health Center, Moorland Reserve Medical Center, and others as applicable.
• Identify problems or obstacles in the system / procedures related to implementation of the research protocols and communicate to the study investigators.
• Assure compliance with all relevant IRB and other regulatory agency requirements.
• Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
• Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW’s Clinical Trial Management System (CTMS) to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Coordinate program outreach activities including acting as a liaison with community organizations.

All remote work must be performed within one of the MCW registered payroll states, which currently includes : WI, AZ, FL, IL, IN, MD, MI, MN, MO, NC, TN,TX, and UT

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.

LI-AV1

Preferred Schedule : Fulltime 8-4 : 30

Position Requirements :

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education : Associate degree

Minimum Required Experience : 1 year

Preferred Education : Bachelor’s degree

Preferred Experience : Regulatory compliance in healthcare field, clinical research

Field : Sciences or compliance

Certification : CITI training within 30 days of hire.

Target salary range for this position is between $51, and $63, annually. The final offered salary will depend on the applicant’s education, experience, skills, and knowledge, as well as considerations of internal equity and market alignment.

Why MCW?

Salary : $51 - $63