Clinical Research Coordinator III

The Alaka`ina Foundation Family of Companies is looking for a Clinical Research Coordinator to support our government customer in Silver Spring, Maryland . Responsibilities Organize and prioritize all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting. Review and understand research protocols, ensuring applicable regulations and guidelines are followed. Coordinate space and supplies with appropriate personnel. Recruit volunteers for the studies, including determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e‑mail. Serve as a volunteer advocate and associated duties. Maintain study/test article accountability and administration. Gather, prepare, and maintain appropriate information and documentation per applicable FDA regulations and ICH guidelines (e.g., source and case report forms, participant rosters, SOPs, etc.). Enter required data on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. Coordinate with external and internal monitors. Assist in training research staff on protocol‑related study methods. Monitor study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA, and other government or locally required guidances. Able to design and create forms, reports, etc. Maintain a safe workplace, observing appropriate safety and occupational health rules and regulations; attend safety training relative to the position and report any infractions to the facility Safety Officer. Other duties as assigned. Required Degree/Education/Certification Registered Nurse licensed to practice in Maryland, skilled in nursing procedures such as phlebotomy and administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with 21 CFR 11, 50, 54, 56, 312, and 314. Basic Life Support (BLS – CPR/AED) certification. Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Required Skills and Experience Four (4) years clinical trials experience. Five (5) years of experience in clinical research coordination, with expertise in FDA‑regulated trials. Experience facilitating clinical monitoring visits and resolving inquiries. Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform). Ability to work both independently and in a team setting. Excellent communication, organization, and prioritization skills. Intermittent physical activity including bending, reaching, and prolonged periods of sitting or standing. May be required to work at any facility and be responsible for own transportation. Work will be scheduled based on operational and business needs. Required knowledge, skills, and abilities; knowledge of applicable highly complex scientific procedures and techniques relating to the position. Physical capabilities: may involve long periods of standing and handling numerous chemicals and/or hazardous biological material. Work environment: clinic/laboratory environment; may require working evenings and weekends. Ability to mentor other clinic staff and to work independently following brief technical training. Ability to establish and maintain effective working relationships with coworkers, managers, and customers. Desired Skills and Experience Advanced Cardiac Life Support (ACLS) certification is encouraged. Certification in clinical research (e.g., CCRP or CCRA) is preferred. Commission for Case Manager Certification (CCMC) preferred. Citizenship and Clearance A Tier I background investigation will be required. Benefits Eligible employees enjoy a 401(k) plan with company match, medical, dental, disability, and life insurance coverage, tuition reimbursement, paid time off, and 11 paid holidays. Equal Opportunity Statement We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We do not discriminate on the basis of any protected class and we E‑Verify all employees. #J-18808-Ljbffr Laulima Government Solutions