Clinical Research Coordinator

Role Description

Gadolin Research is seeking a Clinical Research Coordinator with experience in psychometric and clinical rating assessments to support ongoing clinical trials in psychiatry and neurology. The ideal candidate will have experience in clinical research coordination and administering standardized psychiatric, cognitive, and behavioral assessments, such as MADRS, CDR, CDR-SB, CGI, MMSE, or MoCA.

Prior experience as a clinical trial rater and completion of sponsor-specific rater training or certifications are highly desirable.

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.