Post-Approval Compliance Monitor

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualifiedPost-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.

DESCRIPTION OF RESPONSIBILITIES:

The WRAIR-based clinical research scientific monitoring services (Post-Approval Compliance Monitoring for the IRB) shall include the following tasks:

• 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.

REQUIRED DEGREE/EDUCATION/CERTIFICATION

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

REQUIRED SKILLS AND EXPERIENCE:

• 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

DESIRED SKILLS AND EXPERIENCE:

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

REQUIRED CITIZENSHIP AND CLEARANCE:

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

The Alaka`ina Foundation Family of Companies (FOCs) 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 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 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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