Research Regulatory Specialist Sr - Pediatric Hematology/Oncology/BMT and Clinical Trials
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![]() United States, Wisconsin, Milwaukee | |
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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
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.
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?
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.
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