Clinical Research Coordinator
hace 2 días
Dallas
Job Description About Us At Empathx, we drive equitable access to complex trials at any phase by providing industry-leading patient access, clinical trial management, and analysis across cardiology/nephrology, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline. Position Summary: The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct of clinical research studies in accordance with the protocol, Good Clinical Practice (GCP), applicable federal and state regulations, and Company Standard Operating Procedures (SOPs). The CRC serves as the primary point of contact for study participants and works closely with the Principal Investigator, Sub-Investigators, Sponsors, and Monitors to ensure studies are conducted safely, ethically, and in compliance with all applicable requirements. The CRC manages a concurrent portfolio of three or more studies across Phase I–IV trials, including vaccine studies. Duties and Responsibilities: • Coordinate and conduct study visits in accordance with the protocol, including obtaining informed consent, collecting source data, and administering study procedures and assessments, • Perform clinical procedures as delegated by the Principal Investigator, including phlebotomy, electrocardiograms (EKGs), vital signs, and Fibro Scan assessments, • Manage the coordination of three or more concurrent studies, prioritizing visit schedules and deliverables across protocols, • Screen, recruit, and enroll study participants; verify eligibility against inclusion/exclusion criteria, • Maintain accurate, complete, and timely source documentation and case report forms (CRFs) for all study participants, • Coordinate study participant scheduling, follow-up visits, and study-related procedures with internal staff and external providers, • Collect, process, label, and ship biological specimens in accordance with the protocol and laboratory manual, • Administer and document investigational product/device dispensing, accountability, and reconciliation as delegated by the Investigator, • Identify, document, and report adverse events (AEs) and serious adverse events (SAEs) to the Investigator and Sponsor per protocol and regulatory timelines, • Maintain regulatory binders/eTMF documentation and ensure all required regulatory documents are current, • Prepare for and participate in sponsor monitoring visits, audits, and regulatory inspections; respond to monitor queries in a timely manner, • Enter and query study data into electronic data capture (EDC) systems within required timelines, • Collaborate with the Principal Investigator, Sub-Investigators, and study team to resolve protocol deviations and operational issues, • Maintain working knowledge of assigned protocols, amendments, and the Investigator's Brochure, • Conduct informed consent discussions with prospective participants, ensuring comprehension and voluntary participation prior to enrollment, • Coordinate with sponsors, CROs, and monitors on study start-up activities (site initiation, IRB/IEC submissions, essential document collection), • Maintain the study's recruitment and retention plan; track screening, enrollment, and discontinuation metrics, • Order, receive, store, and maintain accountability of study supplies and investigational product per protocol and SOPs, • Ensure proper calibration, maintenance, and documentation of study equipment, • Coordinate participant travel, reimbursement, and stipend processing where applicable, • Complete protocol deviation/violation documentation and corrective and preventive action (CAPA) plans as needed, • Assist with budget tracking and invoicing related to participant visits and procedures, • Communicate study status, enrollment progress, and issues to the PI and study team in regular team meetings, • Train and mentor new CRCs, Research Assistants, or other site staff as assigned, • Maintain compliance with HIPAA and participant privacy requirements throughout data collection and storage, • Support close-out activities, including final reconciliation of source documents, drug accountability, and archiving, • Support audit and inspection readiness, including participation in sponsor audits, regulatory inspections, and internal quality reviews, • Complete all required SOP training and company-required trainings as assigned and when updated, • Maintain all required licenses and certifications and ensure they remain current and in good standing, • Travel to company meetings, site locations, or study-related activities as required, • Perform other duties as assigned Qualifications: • Bachelor's Degree (BA) from four-year college or university, or one to two years of related experience and/or training, or equivalent combination of education and experience, • Minimum of two (2) years of clinical research experience, • Experience with Phase I–IV clinical trials, including vaccine trials, • Ability to perform phlebotomy, EKGs, vital signs, and Fibro Scan assessments, • Psychiatry/CNS therapeutic area experience is preferred, • Certificates, licenses and registrations required:, • ACRP or SOCRA certification (preferred), • CPR/BLS certification may be required, • · Systems & Technology skills required:, • Spreadsheet Software (Excel);, • Design Software;, • Word Processing Software (Word);, • Electronic Mail Software (Outlook);, • Presentation software (PowerPoint);, • Experience with EDC systems (Realtime), • Experience with CTMS and/or eRegulatory/eTMF platforms (e.g., Realtime), • Experience with EMR/EHR systems, • Other skills required:, • Fluency in Spanish is preferred., • Strong attention to detail and accuracy, • Ability to manage multiple tasks and priorities, • Strong organizational and time management skills, • Ability to work independently and as part of a team, • Effective communication and interpersonal skills, • Ability to maintain confidentiality and professionalism, • Strong problem-solving and critical thinking skills, • Ability to adapt to changing priorities, • Ability to exercise sound judgment and decision-making, • Customer service mindset with focus on patient experience, • Ability to follow protocols, SOPs, and regulatory requirements, • Ability to handle high-pressure or fast-paced environments Physical Requirements and/or environmental factors: • Continually required to stand., • Continually required to walk., • Continually required to sit., • Continually required to utilize hand and finger dexterity., • Occasionally required to climb, balance, bend, stoop, kneel or crawl., • Continually required to talk or hear., • Continually exposed to bloodborne and airborne pathogens or infectious materials., • While performing the duties of this job, the noise level in the work environment is usually moderate, • The employee must, • Occasionally lift and/or move up to 20 pounds., • Specific vision abilities required by this job include:, • Close vision, • Distance vision, • Color vision, • Peripheral vision, • Depth perception, • Ability to adjust focus, • Specialized equipment, machines, or vehicles used:, • EKG machine, Fibro Scan device, phlebotomy supplies, centrifuge, and vital signs monitoring equipment, • This position operates in a clinical research and office setting. The role involves interaction with study participants, healthcare professionals, and research staff. Work may include use of electronic systems and medical equipment, as well as occasional travel to clinical sites or meetings. Equal Opportunity: Empathx is committed to fostering a diverse, inclusive, and equitable workplace where all employees and applicants are treated with respect and dignity. We are proud to be an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, marital status, national origin, ancestry, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law.
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