Travel Clinical Research Coordinator, Lead

Department: Global DeliveryLevel: Individual Contributor______________________________________________________________________________________What We DoCare 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 AreWe 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 OverviewThe Travel Clinical Research Coordinator, Lead’s primary responsibilities are to guide our sites, events, and decentralized environments with expertise in clinical trial operations and Good Clinical Practices (GCP). The lead will utilize 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 Lead will be able to assume a greater study workload, overall level of 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 Lead is a critical thinker and is often the point of on-site escalation at a site, event, or decentralized environment and will need to lead with exceptional communication and calm demeanor.The Lead is exceptionally proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator lead 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 Lead will be mentored by Site Manager(s), Senior Manager(s), and other leaders within clinical operations.What You'll Be Working OnDuties 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, Clinical Conductor, 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 fellow CRCs, research assistants, site staff and/or sub-investigators is completed for required tasksStudy 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 and management• Strong and clear communication skills, both verbally and in writing• Accept accountability for actions and function independentlyPatient Coordination• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment• Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial• Administer delegated study questionnaires, where appropriate.• Collect and evaluate medical records with the support of medically qualified members of the study team.• Complete visit procedures and ensure proper specimen collection, processing and shipment 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• Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)• Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol• Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround• Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.• Monitor patient progress on study medicationDocumentation• Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP• Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.• Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart• Accurately transcribe data to CRF or EDC.• Resolve data management queries and correct source data as needed• Record protocol exemptions and deviations as appropriate with sponsor.• Complete Note(s)-to-File for patient chart and regulatory filing if necessary• Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing• Maintain copies of patient-specific correspondence in source charts• Assist regulatory personnel with completion of continuing/final review reports• 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.Physical And Travel RequirementsExtensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel in the following models:• Two weeks on / One week off deployments• Temporary Event Support (3-7 day deployment durations)• Weekly deployments (one week on, 3-5 days off).• Frequency and length of travel may depend on the length and location of study, site, and event.• Deployments normalize to a 32 to 42-hour work week on average.What You BringKnowledge, Skills, and Abilities:• Excellent working knowledge of clinical trials, medicine and research terminology• Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+• 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.• Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.• 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 supervisionCertifications/Licenses, Education, And Experience• BA/BS in health, nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred• RN or LVN/LPN preferred• Research Professional Certification - CCRC or exam eligibility preferred• A minimum of 3 to 4 years Clinical Research Industry experience• A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.Benefits (Employment Contract – Full Time)PTO/vacation days, sick days, holidays.100% paid medical, dental, and vision Insurance. 75% for dependents.HSA planShort-term disability, long-term disability, and life Insurance.Culture of growth and equality(US Full-Time Employees Only)• PTO/vacation days, sick days, holidays.• 100% paid medical, dental, and vision Insurance. 75% for dependents.• HSA plan• Short-term disability, long-term disability, and life Insurance.• Culture of growth and equality• 401k retirement planDiversity & InclusionWe serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.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.