Wright State Physicians, Inc.
  • - Pharmacology and Toxicology
  • Dayton, OH, USA
  • Full Time
  • Competitive salary and excellent full-time benefits, including Medical, HSA, Dental, Vision, PTO, Tuition Remission with Wright State University and a generous 7.5% company contribution to employee 401(a).

General Summary: An exempt position responsible for the preparation, submission, and maintenance of all regulatory documents for research compliance, contributes to the development of Standard Operating Procedures and compliance policies in clinical research related to regulatory document submissions and maintenance.

Essential Job Responsibilities:
1. Plans, develops and prepares all required regulatory documents, including the completion of the FDA 1572 form and other essential documents for study startups to the Institutional Review Boards (IRB): Wright State University IRB, or Central IRBs
2. Ensures active status for WSP Federal Wide Assurance Number with Office for Human Research Protections
3. Maintains current knowledge of the regulations pertaining to human research protection
4. Seeks funding sources for research and clinical trials for department growth
5. Supports, upholds and assists in the creation of new research policies and with established policies, procedures, and objectives of regulatory agencies: Food and Drug Administration (FDA), International Council of Harmonization (ICH), and Office for Human Research Protections (OHRP) to ensure Good Clinical Practice standards are met or exceeded
6. Establishes and promotes department educational programs to ensure compliance to federal, state, and local regulations for participation in human subject research; assists Department Chair in the academic mission of the department in teaching and research; provides educational support to the WSU Pharm/Tox master's program for clinical research
7. Maintains department's fiscal affairs. Collaborates with Wright State University Pharmacology & Toxicology department accountant on grant funded projects and with WSP accounting for WSP related expenses.
8. Administration of department annual budget and the accounts payable invoicing and tracking to appropriate finance department: WSP or WSU; collaborates with WSU accountant for Pharmacology & Toxicology department to ensure proper management and tracking of federally funded projects
9. Serves as liaison between the Chairman, WSU Boonshoft School of Medicine, WSP, other agencies and individuals through preparing and presenting information for informed decision making; works closely with WSP Corporate organization to coordinate and promote research development; participates in WSP organizational committees, business strategies, staff development and compliance.
10. Assists department in public relations/marketing with the BSOM Communications and Development Departments, and WSP marketing.
11. Other duties as assigned.

Department Specific Job Duties:
1. Assures timelines for required regulatory submissions are met to ensure efficiency and compliance with federal, state or local agencies; including continuing review reports and other required periodic submissions
2. Acts as liaison to investigators and research coordinators for reporting serious adverse events, determining protocol exceptions, reporting of protocol violations and other FDA required reporting events
3. Notifies study team members of study amendments, Investigational Brochure or safety updates
4. Registers clinical studies into clinicaltrials.gov when appropriate and manages said site
5. Archives study documents until designated destruction of records date is reached
6. Prepares the assembly of research regulatory documents for audits, including internal and sponsor monitoring visits; collaborates with Principal Investigator and supervisor of clinical research operations to ensure marketing is reviewed by IRB when appropriate
7. Assists department manager in quality control auditing, maintaining department routine chart audits
8. Consults with WSP CEO to ensure contract language matches informed consent language and budget line items
9. Guides residents and new researchers for direction on the completion of the basic required human subject research, CITI and the assistance to protocol development
10. Negotiates clinical trial budgets with sponsors, as needed

Education/Certifications: Bachelor's degree required and 5-8 years' experience in a clinical trial research environment. Certification by ACRP (Association of Research Professionals) or SOCRA (Society of Clinical Research Associates) preferred.

Experience: Must have clinical research experience working with protocols and informed consents. Familiar with the regulatory agencies for human research protections: IRB, FDA, ICH, OHRP. Applicant must have proven leadership and the ability to function in a professional collaborative manner. Excellent human relations skills, independent judgment, initiative, planning capabilities, and advanced computer skills. Proficient in Excel preferred.

Other Requirements: The employee is expected to protect the privacy of all patient/client information in accordance with Wright State Physicians privacy policies, procedures and practices as required by Federal (and State) law and in accordance with general principles of professionalism as a health care provider.

This position has been closed and is no longer available.
Wright State Physicians, Inc.


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