Clinical Research Coordinator Full-time

Clinical Research Coordinator

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research projects under the direction of the Principal Investigator (PI). This role involves overseeing the daily operations of clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate documentation. The CRC works closely with research participants, clinical staff, and external sponsors to facilitate the smooth execution of studies. This position will be located within the Texas Center for Pediatric and Congenital Heart Disease.

Responsibilities

Study Coordination

• Manages the day-to-day activities of clinical trials.

• Ensures compliance with study protocols and regulatory requirements.

• Coordinates participant recruitment, screening, and enrollment.

• Maintains accurate and timely documentation of study activities.

Data Management

• Collects, enters, and verifies clinical trial data.

• Ensures data integrity and accuracy.

• Prepares data reports for review by the PI and sponsors.

• Manages electronic data capture systems.

Regulatory Compliance

• Prepares and submits regulatory documents to IRBs and other regulatory bodies.

• Ensure ethical approval for studies is maintained, from initial approval through amendments, annual renewals, and terminations.

• Ensures adherence to Good Clinical Practice (GCP) guidelines.

• Maintains regulatory binders and essential documents.

• Coordinates audits and inspections.

Participant Interaction

• Informs and consents study participants.

• Schedules and conduct study visits.

• Monitors participant safety and well-being.

• Provides education and support to participants.

Collaboration and Communication

• Communicates study progress and issues to the PI and research team.

• Liaises with sponsors, monitors, and other external stakeholders.

• Participates in team meetings and training sessions.

• Facilitates effective teamwork and collaboration.

Required Qualifications

• Bachelor's Degree in health-related field.

• 2+ years of experience in clinical research.

• Certification as a Clinical Research Coordinator (CCRC) or eligibility to obtain certification within one year of hire.

Relevant education and experience may be substituted as appropriate.

Preferred Qualifications

• Master's Degree in Clinical Research, Public Health, or a related field.

• 3+ years of experience in clinical research coordination.

• Certification as a Clinical Research Coordinator (CCRC) or equivalent.

• Additional certifications in clinical research or related fields.

Salary Range

$55,000+ depending on experience

Working Environment

• Standard office equipment

• Repetitive use of a keyboard

Required Materials

• Resume/CV

• 3 work references with their contact information; at least one reference should be from a supervisor

• Letter of interest