Title: Part-Time Post Approval Compliance Monitor
Company: The Alak'ina Foundation Family of Companies
Location: Silver Spring, MD
Laulima Government Solutions is looking for a Clinical Research Associate to work in Silver Spring, MD. This is a part-time position @ 20 hours per week. 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. Ensuring that time-sensitive monitoring-visits are performed by a specifically defined deadline.
- Writing reports for monitoring visits, ensuring that the reports accurately reflect all 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 error-identification.
- Developing a monitoring plan including a schedule for conducting routine monitoring for WRAIR and its OCONUS laboratories IAW Routine Monitoring Plan SOP.
- Reviewing/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 regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures.
- Travel anticipated at 20% or less
- Part-Time - 20 hours weekly Educational
- BS and 6 years’ exp
Required Skills and Experience:
- Knowledge and experience in the areas of clinical research and regulatory affairs relating to clinical studies, healthcare management, and technology-based training and education programs
- Experience compiling/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
- CCRP certification through SOCRA
- DoD experience
- Experience with social/behavioral studies preferred
Citizenship and Clearance Requirements:
- Must be a U.S. Citizen due to clearance requirements.
- May start without CAC.
- Will require a NACI investigation.
- Current PUBLIC TRUST clearance would expedite this process.
Laulima Government Solutions LLC is a fast growing government service provider, and is proud to be an equal opportunity employer. Please visit www.laulimags.com.
SOCRA Exp: 8/24/19