Research Regulatory Specialist Sr - Pediatric Hematology/Oncology/BMT and Clinical Trials

Position Description:

Do you want to be on the frontline of research and development fighting childhood cancer?

Do you want to contribute towards the progress of better treatment and prognosis for pediatric cancer patients?

Join our team of researchers at the Medical College of Wisconsin where we are conducting more than 100 clinical trials to better understand childhood cancers and blood disorders and find new ways to treat them.

Under the direction of the research principal investigator and manager, the Research Regulatory Specialist Sr works collaboratively to support hematology, oncology, bone marrow transplant, and cellular therapy clinical trials for pediatric patients.

In this role you will collaborate with the research team to coordinate subject recruitment with disease-based teammates, coordinate the collection, processing, and shipment of biologic specimens, ensure compliance to study protocol guidelines, and accurately report research data.

Breakthroughs in cancer treatment don't happen overnight. They evolve after years of research in the laboratory, then in small groups of patients, and then in larger groups of patients. Be part of that fight!

Purpose

Provide direct oversight to regulatory staff in the MACC Fund Center Clinical Trials Office. Ensure research is conducted in compliance with regulations, procedures, and policies.

Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists, gathering regulatory documents, preparing review committee submissions, amendments and continuing review for human subject research ensuring 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.

Primary Functions

1. Supervises regulatory team including hiring, training, distribution of workload, performance evaluations, and salary recommendations for these direct reports. Comply with MCW policies and procedures for supervision of professional staff.
2. Prepare and/or provide guidance to regulatory team in the electronic IRB system for study initial approval, amendments, and continuing progress reports. Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission.
3. Works collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions and maintaining open communication.
4. 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.
5. 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.
6. Manage program timelines including tracking deadlines for program components.
7. Manage special projects as assigned by Manager and/or CTO Leadership with minimal supervision.
8. Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators.
9. Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures.
10. Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
11. Conduct or coordinate training for program participants and coordinate notifications to study team members regarding annual regulatory education requirements
12. 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.
13. Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.
14. Perform other duties as assigned.

Knowledge - Skills - Abilities

Excellent oral and written communication skills are essential. Proven ability to maintain high accuracy and attention to detail as well as sound judgment in a clinical environment with fast-changing priorities. PC database management including data base maintenance, modifications and query/retrieval abilities. Prior experience in clinical setting with focus on medical records and medical terminology as well as data management. Experience with patient contact and maintenance of patient confidentiality required. Experience in clinical research including familiarity with diagnostic and medical procedures related to Pediatrics and hematology/oncology preferred. Proven supervisory skills essential.

Preferred Schedule:



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

Position Requirements:

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education: Bachelor's Degree

Minimum Required Experience: 5 years

Certification: CITI training within 90 days of hire

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

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 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.

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