IRB Coordinator II - Research Office
Wisconsin, USA
Summary
Responsible for monitoring and ensuring compliance with moderately complex OHRP and FDA regulations and Institutional Standard Operating Procedures.
Primary Responsibilities
Assigned to one or more IRBs, review protocols, amendments, protocol deviations, serious adverse events, and continuing progress reports.
Consult with research coordinators and investigators to provide suggestions for improvements and modifications to submissions.
Provide professional service to the Chair, IRB Committee, and clinical investigators which involve the application of established principles, theories and concepts.
Resolve moderately complex issues involving more advanced research into ethical questions.
Consult with the IRB chair to determine most appropriate course of action for review.
Conduct meeting preparation, and meeting follow-up for human subject protocols.
Draft Standard Operating Procedures for newly creating or existing processes.
Prepare approval letters for signature and other appropriate documents.
Prepare study related documents for review by Chair and/or committee.
Review submitted documents for accuracy and completeness as per IRB regulations.
Other duties as assigned.
Knowledge – Skills – Abilities
Knowledge of biology, chemistry, mathematics, documentation, and records management.
Data utilization, complex problem solving, critical thinking, resource management, and writing skills.
Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education: Bachelor’s degree
Minimum Required Experience: 3 years
Required Certification/Licensure(s): CITI within 90 days of hire
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.
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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.