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 III 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!
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.
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.
Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate clinical needs.
Appropriate experience may be substituted for education on an equivalent basis
Minimum Required Education: Bachelor’s Degree
Minimum Required Experience: 5 years
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Eastern Wisconsin is a vibrant, diverse metropolitan area. MCW is intent on attracting, developing, and retaining a diverse workforce and faculty body that reflects the community we serve. We value diversity of backgrounds, experience, thought, and perspectives to advance excellence in science and medicine. MCW is a welcoming campus community with a strong culture of collaboration, partnership, and engagement with our surrounding community.
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.
EEO/AA – Minorities/Females/Vets/Disability
The Medical College of Wisconsin is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, veteran status, disability or sexual orientation.