Hyperion Biotechnology is seeking an Human Subject Protection Coordinator for Fort Hood (CRDAMC) in Fort Hood, TX .
1. Provide initial review and recommendation of appropriate review categories of projects to include research not involving human subjects, exempt, expedited and full convened board human research protocols. Submitted proposals including protocols, consent forms, supporting documents, study amendments, adverse event reports and continuing review reports will be reviewed by the contractor for compliance with applicable regulations, policies and guidance. Protocols include investigational drugs (pharmaceuticals and biologics) and medical devices in Phase I, II and III clinical trials and a wide variety of human research submitted by military research facilities, academia and industry.
2. Serve as liaison to ensure communications among the Carl R Darnall Medical Center community, BAMC HPA and the BAMC Institutional Review Board (IRB).
3. Provide regulatory guidance and support to researchers regarding regulatory requirements.
4. Assist in orientation, training and continuing education of researchers and may also conduct research protocol assessments on behalf of the BAMC IRB. The contractor will verify that investigators have met BAMC IRB education requirements prior to IRB submission of research protocols.
5. Attend annual regulatory conference. This will help ensure that research conducted at Carl R Darnall Medical Center meets regulatory guidelines.
6. Review pertinent sources (including FDA MedWatch) and notify investigators of information that would affect the conduct of BAMC IRB-approved protocols.
7. Assist in database management of protocols reviewed by the BAMC IRB and will be responsible for generation of relevant reports to support data calls from various organizations.
8. Provide all job-related progress reports/technical reports as requested.
9. Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. 10.Performs light duties and other related duties as required and assigned.
1. Master’s degree or RN with 5 years of related human protections research experience required. CRA with equivalent related human protections experience considered.
2. NAC security clearance is required for scope of work.
3. Must be able to work independently following a brief period of specific technical training.
To apply: Please submit your resume / CV through this website only. No phone calls. Include your availability, citizenship or visa status, desired salary, and references.
Hyperion Biotechnology does not discriminate in hiring on the basis of race, national origin, color, creed, religion, sex, age, disability, veteran status, sexual orientation, gender identity, or associational preference.
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