What are the responsibilities and job description for the Clinical Research Coordinator position at Gadolin Research?
**Interested applicants must be able to interview onsite in Beaumont, TX with 1 day notice. No AI resumes.**
Position Summary
At Gadolin Research, Clinical Research Coordinators (CRCs) are central to our mission of advancing science while delivering patient-centered care. Guided by our ICROP values — Integrity, Commitment to Accountability, Relentless Improvements, Ownership Mindset, and Patient-Centeredness — the CRC manages study operations, ensures compliance, supports participants, and maintains the highest quality standards in clinical research.
Core Responsibilities
Study Operations & Integrity
- Review study protocols with the PI, evaluating feasibility and site resources.
- Coordinate and conduct study visits, including informed consent, eligibility, procedures, and follow-up.
- Support study start-up and close-out activities, ensuring compliance with ICH-GCP, FDA, IRB, and site SOPs.
- Serve as a resource for participants, caregivers, and sponsor/CRO staff.
Regulatory & Accountability
- Work with the regulatory coordinator to prepare and submit IRB applications and amendments.
- Act as the day-to-day liaison with the IRB and Human Research Committee.
- Ensure consistency and compliance across all regulatory documents.
- Participate in protocol operations manual development and adherence.
Data Management & Relentless Improvements
- Accurately enter, verify, and monitor study data in eSource, EDC, CTMS, IWRS/IRT, and related systems.
- Implement quality control measures to ensure accuracy, completeness, and audit readiness.
- Organize and maintain research databases, extracting information for reports,
publications, and sponsor monitoring.
- Recommend workflow enhancements that improve efficiency and compliance.
Ownership Mindset & Collaboration
- Take ownership of assigned studies from screening through database lock.
- Collaborate with physicians, investigators, and site staff to ensure smooth protocol implementation.
- Mentor new coordinators and contribute to a culture of accountability and teamwork.
- Assist PI with manuscript preparation, data graphics, and presentations for internal and external audiences.
Patient-Centered Care
- Recruit, screen, and enroll participants, ensuring a positive and supportive experience.
- Educate participants and caregivers on trial requirements, procedures, and safety expectations.
- Monitor participant well-being and report adverse events promptly.
- Promote retention through compassionate engagement and flexibility.
Skills & Competencies
Technical Skills
- Proficiency with Microsoft Office Suite, Outlook, and database systems.
- Experience with EDC, IWRS/IRT, ePRO, CTMS, and eSource platforms preferred.
- Familiarity with ICH-GCP E6(R2), HIPAA, safety monitoring, and human subject protections.
Clinical Skills (Preferred, Not Required)
- Vital signs, ECG, phlebotomy, medical history, and medical terminology.
Abilities & ICROP Competencies
- Integrity: Uphold ethical standards and accuracy in all trial activities.
- Commitment to Accountability: Meet timelines, maintain documentation, and ensure compliance.
- Relentless Improvements: Identify opportunities to improve site operations and workflows.
- Ownership Mindset: Manage responsibilities proactively and independently.
- Patient-Centered: Prioritize participant dignity, safety, and satisfaction.
- Analytical problem-solving skills with initiative to introduce innovations.
- Strong organizational, communication, and interpersonal skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
Qualifications
- Bachelor’s degree required (life sciences, nursing, or related field).
- Research experience preferred, but strong healthcare or clinical background will be considered.
- Certification (CCRC or equivalent) preferred but not required; training opportunities available.
Work Environment
- Clinical office and patient care setting with routine standing, walking, and sitting.
- Handling biological samples and medical supplies required.
- Occasional travel for training or sponsor meetings.
Job Type: Full-time
Pay: $42,000.00 - $52,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Education:
- Bachelor's (Required)
Experience:
- research coordination: 1 year (Required)
Ability to Commute:
- Beaumont, TX 77702 (Required)
Work Location: In person
Salary : $42,000 - $52,000