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 Ipeers;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. 
• omplete 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

Other Responsibilities

• Review and assess protocol (including amendments) for clarity, logistical feasibility
• 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) 

• 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. 

Certifications/Licenses, Education, and Experience

• Bachelor’s Degree preferred, or equivalent combination of education, training and experience. 
• A minimum of 3 years prior Clinical Research Coordinator experience required 
• Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
• Recent phlebotomy experience required 

Licenses:

• California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health 
• Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners 
• Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health 
• Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health