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, psychiatry, neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline.
About the Role
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. Based on site in Houston, TX, the CRC manages a concurrent portfolio of three to five studies across Phase I-IV trials, with a primary focus on psychiatry and central nervous system (CNS) studies.
What You'll Do:
- 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, vital signs, electrocardiograms (EKGs), and electroencephalograms (EEGs)
- Manage the coordination of three to five 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 in RealTime and sponsor 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
What You'll Bring:
- 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
- Ability to perform phlebotomy, vital signs, EKGs, and EEGs
- Psychiatry/CNS therapeutic area experience is required
- Experience with RealTime (CTMS/eSource)
- Experience with EDC systems, EMR/EHR systems, and Microsoft Office (Excel, Word, Outlook, PowerPoint)
- Fluency in English (verbal and written)
- Strong attention to detail and the ability to manage multiple priorities in a fast-paced environment
- ACRP or SOCRA certification (preferred)
- CPR/BLS certification (preferred
Schedule
Full-time, Monday - Friday, 40 hours per week, on site in Houston, TX.
Physical Requirements
This role requires standing, walking, and sitting for extended periods. It also requires manual dexterity and the ability to lift up to 20 pounds occasionally. The role involves exposure to bloodborne and airborne pathogens.
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.
