Alaka'ina Foundation Family of Companies Clinical Research Associate (Post Approval Compliance Monitor) in Silver Spring, Maryland
Clinical Research Associate (Post Approval Compliance Monitor)
MD - Silver Spring
The Alakaina 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 Keaki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services. The 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
Laulima Government Solutions has an opening for a Clinical Research Associate (Post Approval Compliance Monitor).
Description of Responsibilities:
The candidate shall ensure ongoing research is conducted in accordance with existing regulations, policies and procedures, and provide training, as needed/requested. 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 OCONUS laboratories IAW 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/modification.
Communicating and coordinating effectively with research teams and HSPB colleagues.
Maintaining a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures.
Travel is anticipated at 20% or less
- BS and 6 years’ exp
Required Skills and Experience:
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)
Desired Skills and Experience:
Certified Clinical Research Associate (CCRA)
Laulima Government Solutions 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 10 paid holidays. Laulima Government Solutions is proud to be an equal opportunity employer.
For additional information on Laulima Government Solutions please visit www.laulimags.com.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. 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.