Clinical Research Coordinator II, RN

• Patient Coordination 
  • Prescreen study candidates   
  • Obtain informed consent per Care Access Research SOP .  
  • Complete visit procedures in accordance with protocol.  
  • Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.  
  • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.  
  • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.  
  • Prioritize activities with specific regard to protocol timelines  
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.  
  • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.  
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  
  • Balances protocol needs with patient experience; proactively addresses concerns. 
  • Mentors CRC I peers; provides onboarding and day‑to‑day guidance. 
  • Moderate complexity; mixed visit types, active IP and AE/SAE workflows. 
  • Can operate as solo CRC onsite. 
  • Conducts delegated clinical tasks (RN specific) and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.  
• Clinical Tasks
  • Preparation and administration of Investigational Product (IP; study drug)   
  • Monitor participant for adverse reactions   
  • Perform phlebotomy and insert IV catheters 
  • Conduct delegated clinical procedures as required per protocol  
  • Maintain Investigational Product records in accordance with regulations and sponsor requirements.  
  • Maintain the blinding of all study products where required.    
  • Maintain proper storage, security and temperature for all medications and investigational products.  
• Documentation 
  • Record data legibly and enter in real time on paper or e-source documents   
  • Accurately record study medication inventory, medication dispensation, and patient compliance.  
  • Resolve data management queries and correct source data within sponsor provided timelines  
  • Assist regulatory personnel with completion and filing of regulatory documents.  
  • Assist in the creation and review of source documents.  
• Patient Recruitment 
  • Assist with planning and creation of appropriate recruitment materials.  
  • Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.  
  • Actively work with recruitment team in calling and recruiting subjects   
• Review and assess protocol (including amendments) for clarity, logistical feasibility 
• Ensure that all training and study requirements are met prior to trial conduct.  
• Communicate clearly verbally and in writing.  
• Attend Investigator meetings as required.   
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) 
• Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. 
• Maintain effective relationships with study participants and other care Access Research personnel.
• Owns studies; prioritizes competing demands; mentors CRC I. 

• Ability to understand and follow institutional SOPs.  
• Working knowledge of medical and research terminology  
• Working knowledge of federal regulations, good clinical practices (GCP)  
• Excellent phlebotomy skills 
• Ability to communicate and work effectively with a diverse team of professionals.  
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.  
• Ability to work independently in a fast-paced environment with minimal supervision.  
• Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments.  
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.  
• Operates independently for most study activities; escalates complex issues as needed. 
• Manages stakeholder communications; facilitates visits and meetings. 
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.  
• Strong computer skills  
• Ability to balance tasks with competing priorities.  
• Critical thinker and problem solver.  
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.  
• Friendly, outgoing personality; maintain a positive attitude under pressure.  
• High level of self-motivation and energy.  
• Ability to work independently in a fast-paced environment with minimal supervision.  
• Must have a client service mentality.   

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • A minimum of 3 years prior Clinical Research Coordinator experience required  
• Minimum Experience:
  • Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator   
  • Recent phlebotomy experience required  
  • Minimum 1 year of experience as a RN required 
• Licenses:
  • RN license in good standing required. 
  • Phlebotomy and infusion experience required.