Clinical Research Coordinator III; Registered Nurse

Clinical Research Coordinator III role at Alaka`ina Foundation Family of Companies

Location:

Silver Spring, Maryland
•

Work Hours:

6:00 AM - 2:30 PM

We are seeking a qualified Clinical Research Coordinator to support our government customer in Silver Spring, Maryland.

• Organize and prioritize activities for 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 studies, including determining population availability, advertising venues, and engaging potential volunteers via telephone or email.
• Serve as a Volunteer advocate and perform associated duties.
• Maintain study/test article accountability and administration.
• Gather, prepare, and maintain information and documentation per FDA regulations and ICH guidelines (e.g., source and case report forms, participant rosters, SOPs).
• Enter data on CRFs and audit records, 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 high compliance with GCP, GLP, FDA and other guidances.
• Able to design and create forms, reports, etc.
• Maintain a safe workplace and attend safety training; report any safety infractions.
• Other duties as assigned.

• Licensed Registered Nurse in Maryland, with nursing procedures experience including phlebotomy and administration of experimental vaccines as per protocol guidance and CFR 11, 50, 54, 56, 312, and 314.
• Basic Life Support (BLS – CPR/AED) certification.
• Maintenance of Certification in Clinical Research Coordination by ACRP or 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 using clinical trial management systems and databases (e.g., REDCap and Inform).
• Ability to work independently and in a team.
• Excellent communication, organization, and prioritization skills.
• Intermittent physical activity including bending, reaching, and prolonged sitting/standing.
• May require work at any facility and own transportation.
• Ability to work based on operational and business needs.
• Knowledge of highly complex scientific procedures and techniques related to the position.
• Physical capability to work with chemicals and hazardous materials in a clinic/laboratory environment; may include evenings and weekends.
• Ability to mentor other clinic staff and work independently after training.

• ACLS certification encouraged.
• CCRP or CCRA certification preferred.
• Vaccine formulation/preparation experience preferred.
• CCMC certification preferred.

A Tier I background investigation will be required.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We do not discriminate in employment decisions on protected categories. If you need an accommodation during the application process, please request accommodation. We E-Verify all employees. EOE, including Disability/Vets.