Clinical Research Coordinator III

divh2Clinical Research Coordinator III/h2pTampa, Florida, United States/ppAbout Care Access/ppCare 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./ppWith 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./ph3How This Role Makes a Difference/h3pThe Clinical Research Coordinators 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./ph3How Youll Make An Impact/h3ulliPatient Coordination ulliManages some of the sites most challenging therapeutic areas and study designs/liliHigh complexity; intensive assessments, multi-arm trials, frequent sponsor interaction./liliChampions balancing protocol needs with patient experience and safety across studies; models best practices./liliCan operate as solo CRC onsite/liliPrescreen study candidates/liliObtain informed consent per Care Access SOP/liliComplete visit procedures in accordance with protocol./liliComplete basic clinical procedures per protocol, such as blood draws, vital signs, ECGs, etc./liliReview laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion./liliDiscuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff./liliPrioritize activities with specific regard to protocol timelines/liliMaintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials./liliCoordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives./liliIdentify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)/li/ul/liliDocumentation ulliRecord data legibly and enter in real time on paper or e-source documents/liliAccurately record study medication inventory, medication dispensation, and patient compliance./liliResolve data management queries and correct source data within sponsor provided timelines/liliAssist regulatory personnel with completion and filing of regulatory documents./liliAssist in the creation and review of source documents./li/ul/liliPatient Recruitment ulliAssist with planning and creation of appropriate recruitment materials./liliAssist in development of recruitment plan and obtain listing of potential candidates to contact from subject database./liliActively work with recruitment team in calling and recruiting subjects/li/ul/liliSite Support ulliPrimary point of contact for the site/liliSupports Key Sponsors and CROs/liliResponsible 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/liliSupports training and process improvements./liliAssist Regional Site Director, Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits/liliDevelops and maintains CAPAs, when needed, with approvals from the Regional Site Director/liliReview and assess protocol (including amendments) for clarity, logistical feasibility/liliSets quality standards; prepares for audits; leads corrective actions./li/ul/liliOther Responsibilities ulliLeads complex studies; coaches team; influences site operations./liliEnsure that all training and study requirements are met prior to trial conduct./liliCommunicate clearly verbally and in writing./liliAttend Investigator meetings as required./liliEnsure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)/liliInteract in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management./liliMaintain effective relationships with study participants and other care Access Research personnel./liliDemonstrate deep knowledge about the therapeutic area of responsibility including comprehensive understanding of related Protocol designs, outcomes and timelines/liliDrives improvements; removes barriers; mentors others through change./li/ul/li/ulh3The Expertise Required/h3ulliBilingual in Spanish required/liliAbility to understand and follow institutional SOPs./liliExcellent working knowledge of medical and research terminology/liliExcellent working knowledge of federal regulations, good clinical practices (GCP)/liliAbility to communicate and work effectively with a diverse team of professionals./liliStrong organizational, prioritization and leadership skills and capabilities with a strong attention to detail/liliStrong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel./liliCritical thinker and problem solver/liliFriendly, outgoing personality; maintain a positive attitude under pressure./liliHigh level of self-motivation and energy/liliExcellent professional writing and communication skills/liliAbility to work independently in a fast-paced environment with minimal supervision./liliEngage in continuous independent learning within the therapeutic area of responsibility/liliLeads cross-site communications; represents site with sponsors/CROs./liliHighly autonomous; leads study execution and resolves operational challenges independent/li/ulh3Certifications/Licenses, Education, and Experience:/h3ulliBachelors Degree preferred, or equivalent combination of education, training and experience./liliA minimum of 5 years prior Clinical Research Coordinator experience required/liliPrefer 1 year of experience as a Care Access Research Clinical Research Coordinator/liliRecent phlebotomy experience required ulliCalifornia based roles require National phlebotomy certification by an organization approved by the California Department of Public Health/liliLouisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners/liliWashington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health/liliNevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health/li/ul/li/ulh3How We Work Together/h3ullistrongLocation:/strong This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Tampa, FL clinic./lilistrongTravel:/strong 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./lilistrongPhysical demands associated with this position include:/strong The ability to use keyboards and other computer equipment. ulliWalking, standing, sitting, and driving - 20% each/liliLifting up to, over, and overhead 25 lbs - 20%/li/ul/li/ulpThe expected salary range for this role is $65,000 - $95,000 USD per year for full time team members./ph3Benefits Perks (US Full Time/h3/div