Human Subjects Protection Scientist

The Alaka`ina Foundation Family of Companies (FOC) is looking for a Human Subjects Protection Scientist to support our government customer in Silver Spring, Maryland.

DESCRIPTION OF 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.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Master of Science (MS) in allied sciences with two years IRB regulatory experience; or
• Bachelor's degree in allied sciences with five years IRB regulatory experience

REQUIRED SKILLS AND 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.

DESIRED SKILLS AND EXPERIENCE:

Previous DoD regulatory experience

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must be a U.S. Citizen
• Must be able to pass and maintain an IT III background check

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees

"EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans"

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po`okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit www.alakainafoundation.com

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