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Alaka`ina Foundation Family of Companies · 1 day ago

Human Subjects Protection Scientist

Silver Spring, MD

Full-time

Onsite

Mid, Senior Level

2+ years exp

Alaka`ina Foundation Family of Companies is seeking a Human Subjects Protection Scientist to support their government customer. The role involves providing regulatory and scientific support services for human subjects protection, evaluating research protocols, and ensuring compliance with regulatory requirements.

CharityCommunitiesGovernment

No H1B

U.S. Citizen Only

Responsibilities

Provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR, HSPB to include participating in project/protocol development/modification

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 action received

Reviews and writes a variety of scientifically technical documents for the purposes of evaluating against applicable regulations, policies and procedures

Provides human subjects protection regulatory and scientific support services via the review of research protocols submitted to an Army command and its detachments

Evaluating research protocols and protocol lifecycle actions for compliance with relevant regulatory requirements and drafting a protocol evaluation form (PEF)/pre-review for each review conducted

Managing the approval process for these actions by drafting/triaging review/approval memoranda on behalf of the army command and its detachments

Developing new policies/procedures, as well as recommend revisions to existing policies and procedures, at the request of the TOCOR or HSPB Director

Representing HSPB at meetings pertaining to human subject protection issues, as needed

Participating in site assistance visits to OCONUS laboratories, as needed, and draft site assistance visit (SAV) reports following visits to OCONUS laboratories

Reviewing and documenting investigator’s credentials. The PEF/pre-review will include review and documentation of investigator credentials

Writing protocol minutes and provision of meeting minutes’ excerpts

Providing training in human subjects’ protection and quality of records to investigators and other staff, as needed

Updating the HSPB protocol database/electronic records management system in a timely manner

Assisting in providing support in preparation for IRB meetings, to include preparing/participating in pre-meetings, as well as, setting up/clearing up the room for the day of the meeting

Other duties as assigned by Supervisor

Qualification

IRB regulatory experienceHuman subjects protectionProtocol evaluationDoD regulatory experienceProblem analysisPolicy developmentWritten communicationOral communicationTeam collaboration

Required

Master of Science (MS) in allied sciences with two (2) years IRB regulatory experience; or

Bachelor's degree in allied sciences with five (5) years IRB regulatory experience

Ability to serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed

Have the ability to analyze extremely complex problems and recommend, monitor and execute best practice solutions to executive level management

Good written and oral communication skills, along with the ability to work well in teams

Must be a U.S. Citizen

Must be able to pass and maintain an IT III background check