Clinical Research Coordinator

Position Summary

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical trials (Phase I–IV) at Provecta Research Network. This role serves as the primary point of contact between study participants, investigators, sponsors, and CROs, ensuring that all trial activities are conducted in compliance with the study protocol, FDA regulations (21 CFR Parts 11, 50, 56, 312), ICH-GCP guidelines, and institutional SOPs.

Essential Responsibilities

Study Conduct & Coordination

• Coordinate all aspects of clinical trial execution from site initiation through close-out, including patient screening, enrollment, dosing/treatment visits, and follow-up
• Perform protocol-required assessments including vitals, ECGs, specimen collection, and adverse event documentation
• Maintain accurate, real-time source documentation and case report form (CRF/eCRF) completion
• Manage investigational product (IP) accountability, storage, dispensing, and return logistics in collaboration with pharmacy staff
• Track and report adverse events, serious adverse events, and protocol deviations per sponsor and regulatory requirements

Patient Care & Retention

• Conduct informed consent discussions ensuring participant understanding and voluntary participation
• Serve as the primary liaison for enrolled participants, managing scheduling, visit reminders, travel reimbursement coordination, and retention touchpoints
• Ensure patient safety throughout the study lifecycle, escalating concerns to the Principal Investigator as appropriate

Data & Systems Management

• Enter and manage study data in the Clinical Trial Management System (ClinCompanion/CTMS) and sponsor EDC platforms
• Reconcile source-to-CRF data and resolve queries within sponsor-defined timelines
• Maintain organized and inspection-ready study files (electronic and physical)

Collaboration & Site Support

• Work closely with Principal Investigators, sub-investigators, and site leadership to ensure protocol adherence and patient safety
• Coordinate with regulatory, recruitment, and front desk staff for efficient site operations
• Support and prepare for monitoring visits, audits, and inspections
• Participate in sponsor/CRO calls, team meetings, and ongoing training
• Contribute to CAPA documentation and corrective action implementation as directed

Qualifications

Required

• Bachelor's degree in a life science, nursing, public health, or related field
• Minimum 1 year of clinical research coordination experience in a site-based setting
• Working knowledge of FDA regulations, ICH-GCP, and IRB processes
• Proficiency with EDC systems and electronic medical records
• Strong organizational skills with the ability to manage multiple concurrent studies
• Excellent written and verbal communication skills
• Phlebotomy and basic clinical assessment competency (vitals, ECG)

Preferred

• CCRC, CCRP, or equivalent certification (ACRP or SOCRA)
• Experience across multiple therapeutic areas (nephrology, endocrinology, immunology, general medicine)
• Multi-site or network-level research experience
• Bilingual (English/Spanish) preferred for Houston sites

Compensation & Benefits

• Competitive salary commensurate with experience (Houston market range: $50,000–$68,000 depending on level)
• Health insurance plans
• Paid time off (PTO)
• 401(k) with employer match
• Annual performance-based bonus
• Phone stipend
• Scrub allowance

Job Type: Full-time

Pay: $58,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Life insurance
• Paid time off

Education:

• Associate (Preferred)

Experience:

• Clinical research: 3 years (Required)

License/Certification:

• GCP certificate (Preferred)

Ability to Commute:

• Houston, TX 77054 (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: In person