Regional Travel, Clinical Research Coordinator

Regional Travel, Clinical Research Coordinator Join our team as a Clinical Research Coordinator, responsible for applying Good Clinical Practices (GCP) to screen, enroll, and closely monitor study subjects. You will maintain protocol and regulatory compliance, manage relationships with investigators and participants, and support site operations across multiple locations. Responsibilities Prioritize activities according to protocol timelines. Ensure adherence to FDA regulations and ICH guidelines. Maintain effective relationships with study participants and other Care Access Research personnel. Balance protocol requirements with patient experience and proactively address concerns. Coordinate site visits, including pre-study visits, initiation, and monitoring visits with clinical staff and Sponsor/CRO representatives. Mentor CRC I peers, providing onboarding and day-to-day guidance. Identify and report adverse events (AEs) and serious adverse events (SAEs) to the Principal Investigator and Sponsor. Obtain informed consent per Care Access Research SOP. Execute visit procedures in accordance with protocol (e.g., blood draws, vital signs, ECGs). Review lab results, ECGs, and other test results for completeness and alert values, ensuring timely investigator review. Discuss study medication, procedures, eligibility criteria, and impact on office flow with investigators and site staff. Record data legibly and enter in real time on paper or e‑source documents; manage study medication inventory 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 and source documents. Collaborate on recruitment materials, develop recruitment plans, and contact potential candidates. Review and assess protocol amendments for clarity and logistical feasibility. Ensure all training and study requirements are met before trial conduct. Communicate clearly in writing and verbally; anticipate needs and propose solutions. Attend investigator meetings as required, owning studies and prioritizing competing demands. Ensure adequate supplies arrive on site for protocol initiation. Qualifications Bachelor’s Degree preferred or equivalent education, training, and experience. Minimum 3 years of Clinical Research Coordinator experience. Preferred 1 year of experience as a Care Access Clinical Research Coordinator. Recent phlebotomy experience required. Strong knowledge of GCP, federal regulations, and medical research terminology. Ability to follow institutional SOPs and communicate effectively with diverse teams. Excellent organizational, prioritization, and leadership skills. Strong computer skills in clinical trials database, IVR systems, electronic data capture, MS Word, and Excel. Critical thinker, problem solver, and friendly, outgoing personality. High self-motivation, energy, and positive attitude under pressure. Excellent professional writing and communication skills. Ability to work independently in a fast-paced environment with minimal supervision. Location & Travel On-site daily at local sites within the Southwest region (Thousand Oaks, Huntington Beach, Aurora, Mesa, Ogden). Travel within the region up to 75%; travel length depends on study requirements. Physical demands include use of keyboards and computer equipment. Pay range: $75,000 - $105,000 USD per year for full-time team members. Benefits & Perks (US Full-Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% employer-paid medical, dental, and vision insurance 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 Diversity & Inclusion: We work with and serve people from diverse cultures and communities. We maintain an inclusive culture where all feel valued and respected. We are an equal-opportunity employer; all qualified applicants will receive consideration 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 does not sponsor work visas at this time. #J-18808-Ljbffr