Join the team that is revolutionizing health care - BayCare Health SystemOur network consists of 16 community-based hospitals a long-term acute care facility home health services outpatient centers and thousands of physicians. With the support of more than 30000 team members we promote a forward-thinking philosophy thats built on a foundation of trust dignity respect responsibility and clinical excellence.TitleSupervisor Research RegulatoryFacility BayCare System Office HybridResponsibilities IncludeResponsible for supervising a regulatory specialist team ensuring compliance with regulations managing regulations submissions to Local and Central IRBs and overseeing the preparation of necessary documentation for clinical trials. This role requires strong teamwork communication regulatory knowledge and skills to guide the team to ensure research protocols are conducted in compliance with all regulations. The supervisor directly coordinates regulatory oversight for human subjects research projects administratively approved for use within BayCare registers BayCare-sponsored projects on ClinicalTrials.gov and prepares and submits IND or IDE applications to the FDA for BayCare-sponsored projects as required.Required skills includes extensive knowledge of FDA regulations and human subject protection regulatory knowledge and compliance leadership and team management operational oversight communication and collaboration and analytical and problem-solving skills.BayCare offers a competitive total reward package includingBenefits Medical Dental VisionPaid Time OffTuition Assistance401K Match and additional yearly contributionAnnual performance appraisals and team award bonusFamily resources and wellness opportunitiesCommunity perks and discountsExperience RequirementsRequired - 3 years research regulatory submissions experienceEducation RequirementsRequired - Bachelors Degree in Business or Healthcare ManagementCertification RequirementsPreferred - SOCRA Society of Clinical Research AssociatesPreferred - ACRP Association of Clinical Research ProfessionalsPreferred - CCRC Certified Clinical Research CoordinatorLocation Clearwater FLStatusFull Time ExemptShift Hours800AM - 430PMWeekend WorkNone Equal Opportunity Employer VeteransDisabled