Clinical Research Associate-Part Time

Alaka`ina Foundation Family of Companies
Silver Spring, MD
Jul 27, 2021
Jul 30, 2021
Analyst, Research
Full Time
Laulima Government Solutions, LLC, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Laulima Government Solutions, LLC offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements. Laulima Government Solutions is looking for a Clinical Research Associate to work on our WRAIR Contract in Silver Spring, MD. This is a part-time position @ 20 hours per week. 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 Degree/Education/Certification Requirements: - 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) - 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 - DoD experience - Experience with social/behavioral studies preferred Clearance: May start without CAC. Will require a NACI type investigation. Current PUBLIC TRUST clearance would expedite this process Must be a US Citizen Laulima Government Solutions LLC is a fast growing government service provider, and is proud to be an equal opportunity employer. For additional information on Laulima Government Solutions, LLC, please visit 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. #monster

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