Travel Clinical Research Coordinator

What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.  Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.   Position Overview Based out of the Chicago, IL area, the Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access’ decentralized clinical research process, the Travel Clinical Research Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members.   The Travel Clinical Research Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+.  The Travel Clinical Research Coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Research Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.    What You'll Be Working On Duties include but not limited to:  Study Preparation:   ● Ability to understand and follow institutional SOPs   ● Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.   ● Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct   ● Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff   ● Assist with planning and creation of appropriate recruitment and marketing materials   ● Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. ● Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies   ● Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives   ● Assist in the creation or review of protocol specific source documents   ● Determine facility, equipment and outsource vendor requirements and availability   ● Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance ● Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks     Study Management:   ● Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. ● Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies  ● Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records   ● Collect and evaluate concomitant medications   ● Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. ● Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings   ● Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave   ● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials   ● Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion   ● 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 an