The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trial Monitor (Post-Approval Compliance) to support corporate operations located in Silver Spring, Maryland.
The candidate shall ensure 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:
- Performing routine and for-cause monitoring of human subjects research and protocols that received research determinations to ensure the appropriate regulations were applied during the review of the study, and ensuring the research/activity is conducted as approved. For those monitoring visits considered to be time sensitive, ensuring that these visits are performed within by a specifically defined deadline.
- Writing reports for each monitoring visit, ensuring that the reports accurately reflect the conduct of monitoring activities performed and corrective actions requested/performed by the study team.
- Performing weekly internal reviews of Human Subject Protection Branch (HSPB) files (hard copy and electronic), and updating/correcting files, as necessary, within 5 days of identification of the error.
- Developing a monitoring plan, to include a schedule for the conduct of routine monitoring for WRAIR and its overseas laboratories in accordance with the Routine Monitoring Plan SOP.
- Reviewing and revising existing policies and procedures regarding human subjects protection within 2 weeks of request made by the customer.
- Performing training for WRAIR researchers, IRB, HSPB, and others.
- Participating in project/protocol development or modification.
- Communicating and coordinating effectively with research teams and HSPB colleagues.
- Maintaining a safe workplace, observing appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to the position and report any infractions of safety procedures.
- Travel is possible (anticipated at 25% under normal travel conditions)
- Other duties as assigned by Supervisor.
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
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. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. 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.
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, Kupono Government Services, and Kapili Services, Po`okela Solutions, Kikaha 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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