Clinical Research Coordinator III; Registered Nurse

Job Brief

Work Hours:

6:00 AM - 2:30 PM

Clinical Research Coordinator III (Registered Nurse)

Location:

Silver Spring, MD

• 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, determining volunteer population availability, advertising venues, and discussing 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 guidance.
• 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 of safety procedures to the facility Safety Officer.
• Other duties as assigned.

• Registered Nurse licensed to practice in Maryland, skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per protocol guidance in accordance with 21 CFR 11, 50, 54, 56, 312, and 314.
• Basic Life Support (BLS – CPR/AED) certification.
• Maintain certification in Clinical Research Coordination by the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).

• 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).
• Must be able to work both independently and in a team setting.
• Must have excellent communication, organization, and prioritization skills.
• Intermittent physical activity including bending, reaching, and prolonged periods of sitting and/or standing.
• May be required to work at any facility and be responsible for own transportation.
• 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: work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material.
• Work environment: clinic/laboratory environment; may require working evenings and weekends.
• Must be able to work independently and mentor other clinic staff.
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.

• Advanced Cardiac Life Support (ACLS) certification encouraged.
• Certification in clinical research (e.g., CCRP or CCRA) is preferred.
• Vaccine formulation/preparation experience preferred.
• Commission for Case Manager Certification (CCMC) preferred.

A Tier I background investigation will be required.

Competitive salaries, a 401(k) plan with company match, medical, dental, disability, and life insurance coverage, tuition reimbursement, paid time off, and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action…