Clinical Research Coordinator III

Clinical Research Coordinator – Silver Spring, Maryland

The Alaka`ina Foundation Family of Companies is looking for a Clinical Research Coordinator to support our government customer in Silver Spring, Maryland
.

• 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, to include 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.
• Be 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 the state of 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 specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314.
• Basic Life Support (BLS –CPR/AED) certification.
• Maintain Certification in Clinical Research Coordination by 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 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.
• Commission for Case Manager Certification (CCMC) certification preferred.

A Tier I background investigation will be required.

Employees enjoy competitive salaries. Eligible employees enjoy a 401K 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 Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, click here to request accommodation. We E-Verify all employees.