Clinical Research Coordinator II

How You'll Make An Impact

• Patient Coordination
  • Prioritize activities with specific regard to protocol timelines  
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.  
  • Maintain effective relationships with study participants and other care Access Research personnel.  
  • Balances protocol needs with patient experience; proactively addresses concerns. 
  • Monitors quality metrics; prevents deviations; resolves queries quickly. 
  • Interact in a positive, professional manner with patients, .representatives, investigators and Care Access Research personnel and management.  
  • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.  
  • Mentors CRC I peers; provides onboarding and day‑to‑day guidance. 
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  
  • Moderate complexity; mixed visit types, active IP and AE/SAE workflows. 
  • Can operate as solo CRC onsite. 
  • 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.  

• 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.  
• Anticipates needs; proposes solutions; manages change effectively. 
• Attend Investigator meetings as required.   
• Owns studies; prioritizes competing demands; mentors CRC I. 
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)  

The Expertise Required

• Ability to understand and follow institutional SOPs.  
• Excellent working knowledge of medical and research terminology  
• Excellent working knowledge of federal regulations, good clinical practices (GCP)  
• Operates independently for most study activities; escalates complex issues as needed. 
• Ability to communicate and work effectively with a diverse team of professionals.  
• Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail  
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.  
• Critical thinker and problem solver  
• Friendly, outgoing personality; maintain a positive attitude under pressure.  
• High level of self-motivation and energy  
• Excellent professional writing and communication skills  
• Manages stakeholder communications; facilitates visits and meetings. 
• Ability to work independently in a fast-paced environment with minimal supervision.