Clinical Research Coordinator III
16 days ago
Tampa
Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference 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. The CRC III is responsible for the most pivotal and complex protocols and study designs being conducted at Care Access Research sites. How You'll Make An Impact • Patient Coordination, • Manages some of the sites most challenging therapeutic areas and study designs, • High complexity; intensive assessments, multi‑arm trials, frequent sponsor interaction., • Champions balancing protocol needs with patient experience and safety across studies; models best practices., • Can operate as solo CRC onsite, • Prescreen study candidates, • Obtain informed consent per Care Access SOP, • Complete visit procedures in accordance with protocol., • Complete basic clinical procedures per protocol, 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., • Prioritize activities with specific regard to protocol timelines, • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials., • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives., • 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., • Assist in the creation and review of source documents., • Patient Recruitment, • 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, • Site Support, • Primary point of contact for the site, • Supports Key Sponsors and CROs, • Responsible for mentoring and training CRAs and CRC I/CRC II to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities, • Supports training and process improvements., • Assist Regional Site Director, Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits, • Develops and maintains CAPAs, when needed, with approvals from the Regional Site Director, • Review and assess protocol (including amendments) for clarity, logistical feasibility, • Sets quality standards; prepares for audits; leads corrective actions., • Other Responsibilities, • Leads complex studies; coaches team; influences site operations., • Ensure that all training and study requirements are met prior to trial conduct., • Communicate clearly verbally and in writing., • Attend Investigator meetings as required., • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords), • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management., • Maintain effective relationships with study participants and other care Access Research personnel., • Demonstrate deep knowledge about the therapeutic area of responsibility including comprehensive understanding of related Protocol designs, outcomes and timelines, • Drives improvements; removes barriers; mentors others through change. The Expertise Required, • Bilingual in Spanish required, • Ability to understand and follow institutional SOPs., • 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., • Engage in continuous independent learning within the therapeutic area of responsibility, • Leads cross‑site communications; represents site with sponsors/CROs., • Highly autonomous; leads study execution and resolves operational challenges independent Certifications/Licenses, Education, and Experience:, • Bachelor's Degree preferred, or equivalent combination of education, training and experience., • A minimum of 5 years prior Clinical Research Coordinator experience required, • Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator, • Recent phlebotomy experience required, • California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health, • Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners, • Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health, • Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together, • Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Tampa, FL clinic., • Travel: This role requires up to 10% travel requirements further explained below. Length of regional (within 100 miles) travel will depend upon study requirements, staff needs, and company initiatives., • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment., • Walking, standing, sitting, and driving - 20% each, • 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 We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we 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 are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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. If you need an accommodation to apply for a role with Care Access, please reach out to: Mandatory Employer Disclosures: Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment. Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment. Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws. Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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