Clinical Research Coordinator

American Clinical Research Services Opco LLC•Dallas, TX

7d•$58,240 - $72,800•Hybrid

About The Position

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.

Requirements

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
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
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

Nice To Haves

Psychiatry/CNS therapeutic area experience is preferred
ACRP or SOCRA certification (preferred)
CPR/BLS certification may be required
Fluency in Spanish is preferred.

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