Research Regulatory Specialist Sr (100% remote)

Position Description :

The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research and patient care. Tomorrow's discoveries happen right here alongside the very people who bring those lessons to our students.

Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities.

Purpose

Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation.

Duties include gathering regulatory documents, and preparing review committee submissions. Assists with amendments and continuing review for human subjects research as needed.

Ensure compliance with Federal and State regulations, institutional policies, and Standard Operating Procedures. Perform as the regulatory liaison between sponsors, principal investigators, study team members, and review committees.

Facilitate the achievement of the Cancer Center CTO goals. Lead a team of Research Regulatory Specialists and / pr Coordinators.

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.

Primary Functions

• Prepare and / or provide guidance to Regulatory Specialists to prepare multiple Internal Review Board (IRB) documents.
• Draft and submit protocols, protocol summaries, and consent-to-treat documents with minimal supervision. Following IRB guidelines, draft and / or modify documents as required by research program activities.
• Assist as needed with submission of amendments, protocol deviations, serious adverse events, and continuing progress reports.

Following IRB guidelines, draft and / or modify documents as required by research program activities.

Prepare and / or provide guidance to prepare the required documents in the MCW / Froedtert electronic IRB system for initial approval and amendments, and continuing progress reports as needed.

Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission.

• Coordinate support for Investigator-Initiated IND / IDE applications; maintain IRB and FDA regulatory files for each IND / IDE and ensure routine monitoring is conducted as required.
• Manage study start up activities, as necessary, including submissions to Scientific Review Committee (SRC), Data Safety Monitoring Board (DSMB), Institutional Biosafety Committee, Radiation Safety Committee, MRI Committee, and ClinicalTrials.gov postings.
• Advise CTO Research Managers, Research Nurses, and Research Coordinators to identify, prioritize, and complete all regulatory needs associated with each assigned protocol.
• Manage program timelines including tracking deadlines for program components.
• Mentor and advise others on matters of research administration, research administration systems, processes, and regulations.
• Manage special projects as assigned by Manager and / or CTO Leadership with minimal supervision.
• Identify problems or obstacles in the system / procedures related to implementation of the research protocols and communicate to supervisor and study investigators.
• Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures.
• Collaborate with investigators and CTO Research nurses / study coordinators on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW's Clinical Trial Management System (CTMS) OnCore to assist with meeting regulatory requirements and tracking activities.

Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.

• Coordinate notifications to all study team members regarding annual regulatory education requirements.
• Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.

Knowledge - Skills - Abilities

Knowledge of biology, chemistry, mathematics, documentation, regulatory compliance, interpretation of regulations, and records management.

Oral and written communication skills.

Critical thinking, problem solving, and attention to detail.

Data utilization and resource management.

LI-AV1

Preferred Schedule : 8 : 00 to 4 : 30

8 : 00 to 4 : 30

Position Requirements :

Specifications

Appropriate r experience may be substituted foe education on an equivalent basis

Minimum Required Education : Bachelor's degree.

Minimum Required Experience : 5 years in compliance or healthcare field (3 years if oncology compliance or healthcare field), or 8 years in clinical research compliance or healthcare field without a degree or certification.

Preferred Education : Bachelor's Degree

Preferred Experience : 10 years clinical research regulatory support (5 years if oncology specific). Experience with project management in a medical research or educational environment.

Field : Sciences or compliance, clinical research

Certification : CITI certification required within 30 days of hire. SoCRA and / or ACRP Certified Clinical Research Professional preferred within 6 months of employment or promotion.

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.