Post-Approval Compliance Monitor

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Post-Approval Compliance Monitor to support our government customer located in Silver Spring, Maryland
.

The candidate will verify ongoing research is conducted in accordance with existing regulations, policies and procedures, and provide training, as needed/requested.

• Develop a monitoring plan that includes a schedule for the conduct of routine monitoring for WRAIR and its forward laboratories IAW applicable SOPs. The monitoring plan shall be delivered within three months of TO award and updated annually.
• Perform routine and for-cause monitoring of human subjects research and protocols that receive research determinations. Verify the appropriate regulations are applied during the review of a study and validate that the research/activity is conducted as approved. Perform monitoring visits considered to be time sensitive within timeframe specified by COR.
• For each monitoring visit, draft reports that accurately document the conduct of monitoring activities performed and corrective actions requested/performed by the study team. Provide draft reports to the COR and/or HSPB Director for review and incorporation of feedback within ten business days following a visit.
• Perform weekly internal reviews of hard copy and electronic HSPB files. Update/correct files, as necessary, within five business days of identification of an error. Up to three delays performing weekly review of files, and up to three delays making updates/corrections per year are acceptable.
• Conduct training in human subjects protection, compliance monitoring, and quality of records to investigators, WRAIR researchers, IRB, HSPB, and other staff as needed.

• Bachelor's degree in allied science or related field
• Certification or evidence of training completed in Clinical Trial Monitoring requirements and best practices

• Minimum three (3) years experience as a Clinical Trial Monitor
• Knowledge and experience in the areas of clinical research and regulatory affairs as related to clinical studies, healthcare management, and technology-based training and education programs
• Experience compiling and auditing clinical study packages for IRB review
• Experience monitoring/auditing clinical laboratory use of human subjects and study data
• Working knowledge of Good Clinical Practices (GCP) and Human Subjects Protection (HSP)
• Must possess strong written and verbal communication with the ability to communicate effectively with clinical research personnel

• Certified Clinical Research Professional (CCRP) certification through SOCRA preferred
• DoD experience preferred

• Must be a U.S. Citizen
• Ability to pass a Tier I background investigation.

Benefits:
Competitive salary; 401(k) with company match; medical, dental, disability and life insurance; tuition reimbursement; paid time off; 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. If you are a person with a disability and you need an accommodation during the application process, please  to request accommodation. We E-Verify all employees.

EOE, including Disability/Vets

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