School of Nursing - Clinical Trial Coordinator

School Of Nursing - Clinical Trial Coordinator

The Clinical Trial Coordinator will support the operational, regulatory, and administrative management of clinical research studies conducted under the Clinical Research Operations and Management System (CROMS). This position plays a critical role in ensuring that clinical trials are conducted in compliance with federal regulations, institutional policies, and sponsor requirements. The Clinical Trial Coordinator will work closely with Principal Investigator (PI) and research staff to support the successful execution of grant-funded clinical research projects.

Responsibilities include:

• Coordinate day-to-day operations of assigned clinical trials from study start-up through close-out;
• Assist with participant recruitment, screening, enrollment, scheduling, and follow-up activities in accordance with approved protocols;
• Maintain accurate and up-to-date study documentation, including source documents, case report forms, and study logs; and
• Ensure protocol adherence and promptly identify, document, and report protocol deviations.

• Assist with preparation, submission, and maintenance of regulatory documents to Institutional Review Boards (IRBs), sponsors, and regulatory agencies;
• Ensure compliance with federal regulations and institutional policies;
• Support adverse event and serious adverse event reporting in coordination with the PI;
• Maintain regulatory binders and CROMS documentation systems in an audit-ready state; and
• Assist with REDCap survey design, implementation, data collection, and data management to support research protocols.

• Enter, review, and maintain study data in CROMS and other electronic data capture systems;
• Perform data quality checks and resolve data queries in collaboration with investigators and sponsors; and
• Assist with preparation for monitoring visits, audits, and inspections.

• Serve as a liaison between investigators, sponsors, CROs, CROMS staff, and clinical sites;
• Participate in study meetings, investigator meetings, and training sessions as required;
• Communicate study progress, issues, and timelines to the research team and CROMS leadership; and
• Provide translation support for research survey measures and conduct interviews with participants in English and either Spanish or Korean.

• Assist with tracking study milestones, timelines, and grant-related deliverables;
• Support documentation for grant reporting, renewals, and progress updates as required; and
• Maintain confidentiality of participant data and sensitive research information.

Required qualifications include:

• Bachelor's degree in health sciences, public health, biological sciences, or a related field, or an equivalent combination of education and experience;
• Demonstrated knowledge of clinical research processes and regulatory requirements;
• Strong organizational skills with the ability to manage multiple studies and priorities;
• Excellent written and verbal communication skills;
• Proficiency with electronic research management systems and standard office software; and
• Bilingual proficiency in English and either Korean or Spanish (written and verbal).

Preferred qualifications include:

• Prior experience coordinating clinical trials or working in a clinical research environment;
• Familiarity with CROMS, IRB submission systems, and electronic data capture platforms;
• Training or certification in Good Clinical Practice or clinical research coordination; and
• Experience working on grant-funded research projects.

Instructions to applicants: For full consideration, applicants must apply for Clinical Trial Coordinator (Req#10003756) at Complete and submit the online application to include three professional references with contact information, one of which is a most recent supervisor, and provide a cover letter and resume for review.