Post Approval Compliance Monitor

Kapili Services, LLC; Silver Spring (MD); On-site; USD 88,000 - 99,000; Full time

Benefits offered by this job

401K plan with company match

Medical, dental, disability, and life

Tuition reimbursement

Paid time off

11 paid holidays

Job summary

Kapili Services, LLC invites applications for a Post Approval Compliance Monitor to support the WRAIR HSPB in Silver Spring, MD. The role focuses on developing monitoring plans, conducting regulatory file reviews, and delivering timely training to investigators and staff.

Ideal candidates will have a Bachelor's degree and at least 2 years in clinical research monitoring, with strong knowledge of FDA regulations and documentation practices.

Qualifications

• Bachelor's degree in Biomedical Science, Public Health, Clinical Research, Regulatory Affairs, Psychology, Biology, or related life science disciplines.
• Minimum two (2) years of experience in clinical research monitoring, human subjects research oversight, IRB operations, or regulatory compliance.
• Experience performing monitoring visits, audits, or postapproval reviews of human subjects research.
• Ability to track and meet multiple deadlines consistently.
• Experience presenting training or education on research compliance topics.
• Excellent understanding of FDA regulations relating to human subjects protections, ethical research principles, and compliance practices.
• Strong analytical and document review skills with high attention to detail.
• Ability to work independently, manage multiple priorities, and maintain strict timelines.
• Skilled in presenting regulatory requirements and compliance expectations clearly.

Responsibilities

• Monitoring Program Development: Develop a comprehensive monitoring plan for WRAIR and forward labs; deliver within three months and update annually.
• Routine and ForCause Monitoring: Conduct routine/for-cause monitoring; ensure IRB requirements are applied.
• Reporting and Documentation: Draft monitoring reports; provide drafts within ten business days of each visit.
• Regulatory File Reviews: Conduct weekly reviews of HSPB files; update within five business days; manage delays.
• Training and Education: Provide training on human subjects protection and monitoring best practices; develop training materials.

Skills

Regulatory compliance

IRB operations

Monitoring visits

Report writing

Time management

Training

Education

Bachelor's degree

Master's degree preferred

Job description

Bering-Alaka`ina Holdings (BAH) is looking for a Post Approval Compliance Monitor to provide support for our government customer in Silver Springs, Maryland.

The PostApproval Compliance Monitor supports the WRAIR Human Subjects Protection Branch (HSPB) by conducting routine and forcause monitoring of human subjects research to ensure compliance with federal regulations, DoD policies, institutional requirements, and approved study documents. This role is responsible for developing and executing monitoring plans, performing regulatory file reviews, documenting compliance findings, and providing training to research teams and institutional stakeholders. The Compliance Monitor plays a critical role in ensuring research quality, subject safety, and continuous institutional compliance.

• DESCRIPTION OF RESPONSIBILITIES:

Monitoring Program Development

• Develop a comprehensive monitoring plan for WRAIR and its forward laboratories in accordance with applicable SOPs.
• Deliver the initial monitoring plan within three months of task order award; update the plan annually.
• Ensure deliverables meet deadlines at least 95% of the time, coordinating with the COR for any exceptions.

Routine and ForCause Monitoring

• Conduct routine and forcause monitoring of human subjects research protocols and activities requiring research determinations.
• Confirm appropriate regulations, policies, and IRB requirements are applied during protocol review and execution.
• Validate that studies are conducted in accordance with IRB approvals, institutional policies, and federal/DoD regulations.
• Complete timesensitive monitoring visits within the timeframe specified by the COR, maintaining a 95% ontime completion rate.

Reporting and Documentation

• Draft clear, accurate monitoring reports describing activities performed, findings identified, and corrective actions necessary.
• Provide draft reports to the COR and/or HSPB Director within ten business days of each visit.
• Incorporate feedback promptly to finalize deliverables within required timelines.

Regulatory File Reviews

• Conduct weekly internal reviews of electronic and hardcopy HSPB files to ensure accuracy, completeness, and regulatory compliance.
• Update or correct files within five business days of identifying an issue.
• Maintain compliance with allowable delays: up to three delays per year for weekly reviews and up to three for required updates.

Training and Education

• Provide training to investigators, research staff, IRB members, and HSPB personnel on human subjects protection, compliance monitoring, and regulatory file quality.
• Support development of training materials, presentations, and job aids related to research compliance and monitoring best practices.
• Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

Bachelor's degree in a relevant field such as Biomedical Science, Public Health, Clinical Research, Regulatory Affairs, Psychology, Biology, or related life science disciplines.

REQUIRED SKILLS AND EXPERIENCE:

• Minimum two (2) years of experience in clinical research monitoring, human subjects research oversight, IRB operations, or regulatory compliance.
• Demonstrated experience performing monitoring visits, audits, or postapproval reviews of human subjects research.
• Experience preparing clear, detailed compliance or monitoring reports.
• Ability to track and meet multiple deadlines consistently.
• Experience presenting training or education on research compliance topics.
• Excellent understanding of FDA regulations relating to human subjects protections, ethical research principles, and compliance practices.
• Strong analytical and document review skills with high attention to detail.
• Ability to work independently, manage multiple priorities, and maintain strict timelines.
• Skilled in presenting regulatory requirements and compliance expectations in a clear and approachable manner.
• Strong writing skills for developing professional reports and guidance materials.

DESIRED SKILLS AND EXPERIENCE:

• Minimum three to five (3-5) years of experience in human subjects research oversight, clinical research monitoring, IRB operations, or regulatory compliance.
• Master's degree (MPH, MS Clinical Research, Regulatory Affairs, Bioethics, etc.)
• Hold a monitoring certification (ACRP, SOCRA)
• Experience in a DoD research setting, preferably with WRAIR or similar military medical research organizations.
• Experience conducting forcause compliance investigations.
• Familiarity with ICHGCP and international research compliance standards.
• Experience auditing both electronic and paper regulatory binders.
• Strong communication and interpersonal skills for interacting with investigators, IRB personnel, and research staff.

REQUIRED CITIZENSHIP AND CLEARANCE:

Tier I / NACI

COMPENSATION DETAILS:

• $87,786.64 - $99,237.07
• The compensation range or hourly rate provided is a good faith estimate at the time of posting. Final compensation will be determined based on qualifications, experience, skills, internal equity, market conditions, and applicable laws.

Bering-Alaka`ina Holdings, LLC is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy 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 not illegally discriminate in employment decisions on the basis of any protected categories. We E-Verify all employees.

As a part of BSNC, Bering- Alakaina Holdings gives hiring, promotion, training, and retention preference to BSNC shareholders, descendants and shareholder spouses who meet the minimum qualifications for the job. Qualified job candidates will generally be considered in the following order: BSNC shareholders, descendants, shareholder spouses, current employees, and outside candidates. The BSNC Shareholder Development department tracks and monitors the implementation of the Shareholder Hire Preference across its operations.

Bering-Alaka`ina Holdings, LLC is comprised of industry-recognized government service firms designated as Alaska Native Corporation (ACN)-owned and 8(a) certified businesses and includes Ke`aki Technologies, LLC; Laulima Government Solutions, LLC; Kpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kkaha Solutions, LLC; and Pololei Solutions, LLC.

For additional information, please visit www.beringalakaina.com