Clinical Research Regulatory Coordinator

Job SummaryThe Clinical Research Regulatory Coordinator acts as an agent of the investigators and research team conducting sponsored and independent clinical trials.. The purpose of the Clinical Research Regulatory Coordinator is to perform study specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations (FDA Regulations, Good Clinical Practice Guidelines and ICH Guidelines) institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes under the direction of their leader.Dedicated to excellence in all aspects of clinical research with a keen focus on ethics, safety, quality, compliance, and stewardship.Come join a remarkable team where quality care meets quality service, in every dimension, every time.Positions are primarily on-site, Monday through Friday. Some positions may offer Hybrid work opportunities.#JoinTeamAubergine #NovantHealth Let Novant Health be the destination for your professional growth.At Novant Health, one of our core values is diversity and inclusion. By engaging the strengths and talents of each team member, we ensure a strong organization capable of providing remarkable healthcare to our patients, families and communities. Therefore, we invite applicants from all group dynamics to apply to our exciting career opportunities. ResponsibilitiesIt is the responsibility of every Novant Health team member to deliver the most remarkable patient experience in every dimension, every time.Our team members are part of an environment that fosters team work, team member engagement and community involvement.The successful team member has a commitment to leveraging diversity and inclusion in support of quality care.All Novant Health team members are responsible for fostering a safe patient environment driven by the principles of "First Do No Harm". QualificationsCandidates who meet any qualification level outlined below are encouraged to apply!Non-Nursing Levels:Clinical Research Regulatory CoordinatorClinical Research Regulatory Coord IIClinical Research Reg Coord IIINo experience required. Prefer previous experience in clinical research or healthcare setting such as Lab, billing, coding, insurance, phlebotomy, pharmacy, physician practicesMinimum 5 years* of clinical or clinical research experience required. 2 years must be in clinical researchMinimum 8 years* of clinical or clinical research experience required. 5 years must be in clinical research. Certification in Clinical Research required.*** Education may count toward years of experience.** Accepted certifications in Clinical Research include the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Associates (SOCRA), Regulatory Affairs Professionals Society (RAPS) or Public Responsibility in Medicine and Research (PRIM&R).Additional Skills (required): Proficient in Microsoft Office applications, Microsoft Teams, Zoom, Adobe Acrobat, and external portals used by clinical research business partnersAbility to read, understand and implement institutional review board policies and procedures, Code of Federal Regulations, Good Clinical Practice Guidelines, ICH guidelines, and standard operating procedures.Understanding of medical terminology.Planning and coordination of many moving pieces to achieve the desired result.Project and time management skills.Advanced computer skills. Job Opening ID 44275