The Alaka`ina Foundation Family of Companies (FOCs) is looking for a Clinical Research Coordinator II to work with our government customer in Silver Spring, Maryland.

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.
• Other duties as assigned.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

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)
• DoD experience