Regional Travel, Clinical Research Coordinator

Regional Travel, Clinical Research Coordinator Thousand Oaks, California, United States Responsibilities 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. Balance protocol needs with patient experience; proactively address concerns. Interact in a 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. Mentor CRC I peers; provide onboarding and day‑to‑day guidance. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate). Handle moderate complexity; mixed visit types, active IP and AE/SAE workflows. 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. 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. Ensure that all training and study requirements are met prior to trial conduct. Communicate clearly verbally and in writing. Anticipate needs; propose solutions; manage 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). Expertise Required Ability to understand and follow institutional SOPs. Excellent working knowledge of medical and research terminology. Excellent working knowledge of federal regulations and GCP. Operate 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 with 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. Benefits & Perks (U.S. Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays. 100% Employer‑paid medical, dental, and vision insurance plan options. Health Savings Account and Flexible Spending Accounts. Bi‑weekly HSA employer contribution. Company paid Short‑Term Disability and Long‑Term Disability. 401(k) Retirement Plan with Company Match. The expected pay range for this role is $75,000 - $105,000 USD per year for full‑time team members. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. #J-18808-Ljbffr Care Access