Human Subjects Protection Scientist
Knowesis Inc.
Date: 3 weeks ago
City: Silver Spring, MD
Contract type: Full time
Position: Human Subjects Protection Scientist
Location: Silver Spring, MD
Work Environment: Onsite
Clearance Required: Public Trust
Status: Contingent
Knowesis is currently seeking an exceptional Human Subjects Protection Scientist to join our team and provide invaluable support to the Walter Reed Army Institute of Research, Human Subjects Protection Branch (HSPB). The HSPB oversees WRAIR's human research studies, ensuring strict adherence to moral, ethical, and legal standards. Members of HSPB serve the WRAIR community by advising the Commander on human subjects research matters; providing administrative support to the WRAIR Institutional Review Board (IRB); developing human subjects research policies and procedures; and managing the approval process for all research involving human subjects for the WRAIR and its CONUS and OCONUS units.
To be eligible for this position, candidates must have the ability to obtain a Public Trust clearance and possess U.S. Citizenship without the need for sponsorship, both now and in the future. Applicants without proof of U.S. Citizenship will not be considered due to the position’s security clearance requirements.
The Job Duties and Responsibilities include but are not limited to the following:
Human Subjects Protection Scientists will provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR HSPB. Specifically, the Scientist will evaluate research protocols and protocol lifecycle actions (e.g., amendments, continuing reviews, safety reports, deviations, etc.) for compliance with relevant regulatory requirements and draft a protocol evaluation form (PEF)/pre-review for each review conducted; manage the approval process for these actions by drafting/triaging memoranda and obtaining the necessary level of review/approval on behalf of the HSPB, IRB, and WRAIR Command; and develop new and recommend revisions to existing policies and procedures.
Required Qualifications:
Location: Silver Spring, MD
Work Environment: Onsite
Clearance Required: Public Trust
Status: Contingent
Knowesis is currently seeking an exceptional Human Subjects Protection Scientist to join our team and provide invaluable support to the Walter Reed Army Institute of Research, Human Subjects Protection Branch (HSPB). The HSPB oversees WRAIR's human research studies, ensuring strict adherence to moral, ethical, and legal standards. Members of HSPB serve the WRAIR community by advising the Commander on human subjects research matters; providing administrative support to the WRAIR Institutional Review Board (IRB); developing human subjects research policies and procedures; and managing the approval process for all research involving human subjects for the WRAIR and its CONUS and OCONUS units.
To be eligible for this position, candidates must have the ability to obtain a Public Trust clearance and possess U.S. Citizenship without the need for sponsorship, both now and in the future. Applicants without proof of U.S. Citizenship will not be considered due to the position’s security clearance requirements.
The Job Duties and Responsibilities include but are not limited to the following:
Human Subjects Protection Scientists will provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR HSPB. Specifically, the Scientist will evaluate research protocols and protocol lifecycle actions (e.g., amendments, continuing reviews, safety reports, deviations, etc.) for compliance with relevant regulatory requirements and draft a protocol evaluation form (PEF)/pre-review for each review conducted; manage the approval process for these actions by drafting/triaging memoranda and obtaining the necessary level of review/approval on behalf of the HSPB, IRB, and WRAIR Command; and develop new and recommend revisions to existing policies and procedures.
Required Qualifications:
- MS in allied sciences and 2 years Institutional Review Board (IRB) experience or BA/BS in allied sciences and 5 years IRB experience
- IRB regulatory experience is a requirement
- DoD regulatory experience preferred
- Health (PPO & HDHP) Insurance, Dental, Vision, STD & LTD, Basic Life Insurance, 401k Company Match, & Voluntary Products.
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