Clinical Research Coordinator

American Clinical Research Services Opco LLC • Houston, TX

4d • $60,000 - $72,000 • Onsite

About The Position

The Clinical Research Coordinator (CRC) coordinates and conducts clinical research studies in accordance with study protocols, Good Clinical Practice (GCP), applicable federal and state regulations, and company Standard Operating Procedures (SOPs). The CRC is the primary point of contact for study participants and works with the Principal Investigator, Sub-Investigators, sponsors, and monitors to ensure safe, ethical, and compliant study conduct.

Based on site in Houston, Texas, the CRC manages three to five concurrent Phase I–IV studies, primarily in psychiatry and central nervous system (CNS) therapeutic areas. The role involves participant recruitment and visits, clinical procedures, study documentation and data entry, regulatory coordination, investigational product accountability, and collaboration with the study team. The CRC also supports monitoring, audits, inspections, study close-out, and staff training.

Requirements

• Bachelor's degree from a four-year college or university, or one to two years of related experience and/or training, or an equivalent combination of education and experience.
• At least two years of clinical research experience.
• Experience with Phase I–IV clinical trials.
• Ability to perform phlebotomy, vital signs, EKGs, and EEGs.
• Psychiatry or CNS therapeutic-area experience.
• Experience with RealTime (CTMS/eSource).
• Experience with EDC systems, EMR/EHR systems, and Microsoft Office, including Excel, Word, Outlook, and PowerPoint.
• Fluency in spoken and written English.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Ability to meet the physical requirements of standing, walking, and sitting for extended periods; manual dexterity; occasional lifting up to 20 pounds; and exposure to bloodborne and airborne pathogens.
• Ability to travel to company meetings, site locations, or study-related activities as required.

Nice To Haves

• ACRP or SOCRA certification.
• CPR/BLS certification.

Responsibilities

• Coordinate and conduct protocol-compliant study visits, including informed consent, source-data collection, and study procedures and assessments.
• Perform clinical procedures delegated by the Principal Investigator, including phlebotomy, vital signs, electrocardiograms (EKGs), and electroencephalograms (EEGs).
• Coordinate three to five concurrent studies and prioritize visit schedules and deliverables across protocols.
• Screen, recruit, and enroll participants and verify eligibility against inclusion and exclusion criteria.
• Maintain accurate, complete, and timely source documentation and case report forms (CRFs).
• Coordinate participant scheduling, follow-up visits, and study procedures with internal staff and external providers.
• Collect, process, label, and ship biological specimens according to protocols and laboratory manuals.
• Administer and document investigational product or 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 within protocol and regulatory timelines.
• Maintain regulatory binders and eTMF documentation and keep required regulatory documents current.
• Prepare for and participate in sponsor monitoring visits, audits, regulatory inspections, and internal quality reviews; 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 and ensure prospective participants understand and voluntarily agree to participate before enrollment.
• Coordinate study start-up with sponsors, CROs, and monitors, including site initiation, IRB/IEC submissions, and essential-document collection.
• Maintain recruitment and retention plans and track screening, enrollment, and discontinuation metrics.
• Order, receive, store, and maintain accountability for study supplies and investigational products according to protocols and SOPs.
• Ensure study equipment is properly calibrated and maintained and that related documentation is complete.
• Coordinate participant travel, reimbursement, and stipend processing where applicable.
• Complete protocol deviation or violation documentation and corrective and preventive action (CAPA) plans as needed.
• Assist with budget tracking and invoicing for participant visits and procedures.
• Communicate study status, enrollment progress, and issues to the PI and study team in regular meetings.
• Train and mentor new CRCs, Research Assistants, and other site staff as assigned.
• Maintain compliance with HIPAA and participant privacy requirements during data collection and storage.
• Support study close-out, including final reconciliation of source documents, drug accountability, and archiving.
• Complete required SOP and company training, including updated training as assigned.
• Maintain required licenses and certifications in good standing.
• Travel to company meetings, site locations, or study-related activities as required.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level