Medical College Of Wisconsin Inc.
Research Regulatory Specialist - Pediatrics
Milwaukee, WI
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About the role
- 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.
Requirements
- Required Certification /Licensure( s): CITI certification required within 30 days of hire
- Ability to detect and translate speech or other communication required.
- May occasionally require the ability to distinguish colors and perceive relative distances between objects.
- Required Certification /Licensure( s):
- CITI certification required within 30 days of hire
- 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: 2 years in compliance or healthcare field
- Preferred Certification / Licensure (s): SoCRA and ACRP certification preferred.
- 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
Nice to have
- Prepare and submit required documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports.
- Review submissions for accuracy, completeness, and compliance using established checklists prior to submission.
- Maintain IRB and FDA regulatory files for each IND/IDE and ensure required routine monitoring is conducted.
- Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring Board, Institutional Biosafety Committee, or Radiation Safety Committee.
- Manage ClinicalTrials.gov postings as required.
- Identify and resolve problems or obstacles related to research protocol implementation.
- Communicate issues to supervisors and study investigators.
- Ensure all regulatory activities comply with applicable federal and state laws, as well as institutional standard operating procedures.
Compensation
- Coordinate notifications to study team members regarding annual regulatory education requirements.
Benefits
- 2 years in compliance or healthcare field
- 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
- On campus Fitness Facility, offering onsite classes
Equal opportunity
- MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:
- The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer.
This listing is sourced directly from Medical College Of Wisconsin Inc.'s careers page and normalized into a canonical job model.