Summary 

Supervise regulatory personnel, and responsible for overseeing daily operations, quality and timeliness of regulatory activities. 

Primary Responsibilities  

• Supervise staff including overseeing daily operations of the regulatory team to ensure compliance with state and federal regulations. 

• Develop, improve, and apply standard education, processes, and procedures requiring specialized experience to assure timely, quality, and compliant work in conjunction with Regulatory CRQA Specialist and Regulatory Manager. 

• Ensure creation and maintenance of accurate, timely and compliant regulatory records and data, providing information for evaluation and specific recommendations for improvement. 

• Operationalize and implement proposed solutions or process improvements related to identified problems or obstacles in the system/procedures related to implementation of the research protocols.  

• Draft, submit, and advise on regulatory submissions including but not limited to protocols, protocol summaries, amendments, protocol deviations, serious adverse and other reportable events, continuing progress reports, and consent-to-treat documents without need for supervision. Following IRB and IBC guidelines, prepare and/or provide guidance to Regulatory Specialists for drafting/modifying IRB and IBC documents or other safety committee and regulatory documents as required by research program activities. 

• Keep abreast of changing regulations and regulatory techniques and methodologies that might facilitate designated research projects. 

• Demonstrate processes and procedures and provide individualized instruction for regulatory staff and other partners as required 

• Perform as a regulatory specialist/coordinator for select projects as needed.   

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

• Manage other data systems, such as Florence, RightFax, and eBridge which support research activities.  Correspond with local and central IRBs as needed.  

• Work closely with other teams and departments to advance the department’s research goals. 

This position is 100% remote. All remote work must be performed within one of the MCW registered payroll states, which currently includes: WI, AL, AZ, DE, FL,

GA, IL, IN, MD, MI, MN, MO, NC, TN, TX, and UT

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. 

Qualifications 

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education:  Bachelor’s degree 

Minimum Required Experience:  5 years in compliance or healthcare field 

Required Certification/Licensure(s):   CCRC or CCRP required. CITI training required within 90 days of hire. 

Preferred Certification/Licensure(s):   

Physical Requirements 

Work requires occasionally lifting moderate weight materials, standing, or walking continuously. 

Work Environment 

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment. 

Sensory Acuity 

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects. 

#LI-AV1

Target salary range for this position is between $75,300.00 and $95,900.00 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?

• 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
• Employee & Family Assistance Program (EFAP)
• 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 brief overview of our benefits see: Benefits Overview

For a full list of positions see: MCW Careers

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – Collaborative – Curiosity – Inclusive – Integrity – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.

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 an inclusive 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.