Clinical Research Coordinator II

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP) s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

• Duties include but not limited to:
  • Ability to understand and follow institutional SOPs.
  • Review and assess protocol (including amendments) for clarity, logistical feasibility
  • Ensure that all training and study requirements are met prior to trial conduct.
  • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
  • 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
  • Attend Investigator meetings as required.
  • Coordinate and attend pre‑study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
  • Assist in the creation and review of source documents.
  • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
• Study Management
  • 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.
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
  • Communicate clearly verbally and in writing.
• Patient Coordination
  • Prescreen study candidates
  • Obtain informed consent per Care Access Research SOP
  • Complete visit procedures in accordance with protocol.
  • Train others and 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.
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
• 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.
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all inclusive.

• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• 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
• Ability to work independently in a fast‑paced environment with minimal supervision.

• 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
• Bilingual in Spanish‑preferred

• Location:
  
  This is an on‑site position with regional commute requirements. Position requires onsite work 5 days per week at the Santa Clarita, CA clinic.
• Trave…