Clinical Research Coordinator – New Caney, TX
We are seeking an experienced Clinical Research Coordinator to support the launch and daily operations of a clinical research site in New Caney, Texas. The ideal candidate must have prior hands-on experience working in clinical research site settings and a strong understanding of study coordination, regulatory documentation, patient recruitment, sponsor communication, and protocol compliance.
This position requires a knowledgeable, organized, and proactive professional who can help ensure studies are conducted accurately, ethically, and in accordance with applicable regulations, study protocols, sponsor requirements, and site procedures.
Key Responsibilities
- Coordinate and manage assigned clinical research studies from start-up through closeout.
- Review study protocols and ensure site activities are completed according to protocol requirements.
- Screen, recruit, and schedule study participants based on inclusion and exclusion criteria.
- Assist with informed consent processes and ensure proper documentation is completed.
- Maintain accurate and complete source documents, regulatory binders, study logs, and participant records.
- Communicate with sponsors, CROs, monitors, investigators, and study team members as needed.
- Prepare for and participate in monitoring visits, audits, and sponsor meetings.
- Track study visits, assessments, lab work, procedures, and required follow-up.
- Enter and update study data in electronic data capture systems accurately and timely.
- Support investigational product accountability, specimen handling, and study supply tracking as applicable.
- Ensure compliance with GCP, ICH guidelines, IRB requirements, HIPAA, and all applicable regulatory standards.
- Assist with patient outreach and community engagement efforts related to study recruitment.
- Help develop and maintain site workflows to support efficient and compliant research operations.
Required Qualifications
- Minimum of 5 years of experience working in clinical research, preferably in a clinical research site environment.
- Prior experience as a Clinical Research Coordinator, Lead CRC, Research Assistant with advanced site responsibilities, or similar research site role.
- Strong understanding of clinical trial processes, study visits, regulatory documentation, informed consent, and sponsor/CRO communication.
- Experience with patient recruitment, screening, scheduling, and source documentation.
- Familiarity with GCP, ICH, IRB requirements, HIPAA, and clinical research compliance standards.
- Ability to work independently and assist with building efficient research site operations.
- Strong organizational skills and attention to detail.
- Professional communication skills with patients, investigators, sponsors, monitors, and internal team members.
- Comfortable using electronic medical records, EDC systems, email, spreadsheets, and study management platforms.
Preferred Qualifications
- Experience working with multiple therapeutic areas.
- Experience assisting with research site start-up or new study activation.
- Bilingual English/Spanish preferred.
- Phlebotomy, vital signs, ECG, lab processing, or medical assistant experience is a plus.
- Clinical research certification such as CCRC, CCRP, or ACRP certification is preferred but not required.
Ideal Candidate
The ideal candidate is someone who has already worked in established research clinic sites and understands how clinical studies are managed in real-world site operations. This person should be able to take initiative, identify what is needed to keep studies compliant, communicate professionally with sponsors and monitors, and help support the development of a strong research program.
Job Location: New Caney, Texas
Position Type: Full-Time
Experience Required: Minimum 5 years of clinical research site experience
Pay: $30.00 - $40.00 per hour
Work Location: In person
