Research Regulatory Specialist - Pediatric Hematology / Oncology / BMT

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. In the role of a Research Regulatory Specilaist you will be working in our Pediatrics Department.

Member of the MACC Fund Research Regulatory team, responsible for preparing regulatory documents, preparing IRB / CIRB applications, IND / IDE applications, protocol amendments and continuing review for human subject research ensuring compliance with Federal, State and Institutional Standard Operating Procedures. This Research Regulatory Specialist will function as the regulatory liaison between principal investigators, sponsors, study team members and regulatory agencies (IRB, FDA).

Primary Responsibilities

• Provide main administrative support for the preparation of multiple Internal Review Board (IRB) documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and informed consent documents. Following IRB guidelines, draft and / or modify documents as required by research program activities.
• Prepare the required documents in the MCW and / or CHW electronic IRB system for initial approval, amendments and continuing progress reports. Review for accuracy and completeness and identify problems prior to IRB submission
• Facilitate regulatory start up activities, as necessary, including but not limited to, Data Safety Monitoring Board (DSMB), Institutional Biosafety / Radiation Safety Committee, and ClinicalTrials.gov postings.
• Work closely with Research Leadership and study teams to identify and complete all regulatory needs associated with each assigned protocol.
• Develop and formalize Quality Assurance process for internal audits of research charts / records. Identify problems or obstacles in the system / procedures related to implementation of the research protocols and communicate to supervisor and study investigators. Attend all internal / external audits (MCW, Sponsor, FDA, etc).
• Support faculty with Investigator-Initiated IND / IDE applications; maintain IRB and FDA regulatory files for each IND / IDE and ensure routine monitoring is conducted as required.
• Assure that the regulatory activities comply with various federal and state regulations, and institutional standard operating procedures.
• Develop and maintain departmental Standard Operating Procedures for research-related activities.
• Maintain program timeline including tracking deadlines for program components. Utilize OnCore 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 notifications to all study team members regarding annual regulatory education requirements (i.e. CITI, Radiation Safety, etc.). Maintain investigator NCI-registration as necessary.
• Work with Principal Investigators to develop, implement, and maintain comprehensive databases and files related to the program.
• Collaborate with investigators and research teams on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Perform other duties as assigned.

Knowledge - Skills - Abilities

#LI-AV1

Preferred Schedule :

Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.

Position Requirements :

Qualifications

Appropriate experience may be substituted on equivalent basis.

Minimum Required Education : Bachelor's degree

Minimum Required Experience : 2 years' experience

Preferred Education : Previous experience in healthcare research or compliance

Preferred Experience : 3 years, 1 of which is in clinical research, medical, or similar support

Required Certification / Licensure(s) : CITI training required within 30-days of hire

Preferred Certification / Licensure(s) : Certification by SoCRA or ACRP

Why MCW?

For a full list of positions see : www.mcw.edu / careers

For a brief overview of our benefits see : departments / human-resources / benefits

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.

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.