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Associate Research Compliance Specialist Print
Employer: Sanford Health
Employment Type: Full Time

Ensure compliance with the federal and state laws, regulations, and rules governing healthcare clinical research trials. This includes the rules and regulations concerning Conditions of Participation, Code of Federal Regulations, Good Clinical Practice and other regulations that govern clinical research trial/studies. Will be expected to review and prepare clinical trial documentation for submission of new clinical trials, annual reviews, amendments, addendums and updates to the Institutional Review Board. Must maintain accurate records and data base for volume of clinical trials in preparation for sponsor, cooperative group or FDA audits and/or inspections. Responsible for organizing and maintaining up to date clinical trial information, including study protocols and informed consent forms, for accurate presentation to physicians and study staff to ensure patient safety. Directly communicates with sponsors, study staff and Institutional Review Board Coordinators as it relates to study specific document modifications and Institutional Review Board requested revisions.Must have health care knowledge or background in clinical research and/or medical terminology. Requires excellent interactive skills, as well as written and verbal communication skills. Must be able to demonstrate appropriate conflict resolution in stressful situations. Must be able to communicate assertively and collaboratively with all staff. Requires excellent organizational skills with attention to detail. Must demonstrate a high level of integrity, ethical conduct, and trust worthiness. Skillful at managing conflict. Must understand and apply a systems approach to problem solving and process improvement involving staff. Must be competent in computer skills i.e. Access, Excel, Word.

Will be responsible for professional and administrative management of the institution’s Animal Care and Use Committee (IACUC). In addition, will support the Animal Resource Center business operations.Ensures submitted research is reviewed efficiently and consistently with federal regulation and Sanford Policy. Maintains accurate records of Institutional Animal Care and Use Committee (IACUC) operations, conveys IACUC determinations in minutes and Investigator communications. Serves as the IACUC interface and demonstrates professionalism when interacting with research investigators, regulatory agencies, the Institutional Official, IACUC members, and IACUC chair. Provides service to the Animal Resource Center (ARC) business operation by invoicing internal investigators and external clients, ordering, inventory control, prepares financial reports, maintain database records to assure compliance with regulatory agencies. Demonstrates the ability to utilize software applications for maximum efficiency. Maintains strict confidentiality of sensitive information. Exhibits attitude and ability to evolve skills to changes in process and contribute to process evaluation. Must be self-directed with a high level of accountability and works with minimal supervision. Functions as a resource for employees and investigators. Must have excellent time management and organizational skills. Must have excellent communication skills relating in person or on telephone.

Certified Professional in IACUC Administration (CPIA) preferred; Must obtain CPIA once eligible Bachelor's Degree required or a combination of education and experience.

Contact Information

Sanford Health
Phone: 877-243-1372

Other Information

Category(s): Research, BioTech, Other
Industry: Healthcare / Health Services
Experience Req.: Yes
Degree Req.: Yes
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