Data Coordinator - Full Time - Wolf River
About The Position
The Data Coordinator (DC) manages clinical trial data in close collaboration with Sponsors/CROs, investigators, research coordinators, and internal departments. The role is responsible for accurate, timely completion of case report forms (CRFs), resolution of data queries, and coordination during monitoring visits. It requires professionalism, attention to detail, and strict adherence to confidentiality standards. The Data Coordinator supports study data quality and trial operations by completing and reviewing CRFs, following up on missing information, maintaining study logs, preparing for monitoring visits and potential audits, and serving as a liaison among coordinators, monitors, and regulatory affairs. The position also participates in meetings and develops timelines based on project priorities.
Requirements
- Bachelor’s degree, or three years of relevant experience in healthcare or clinical research, or an equivalent combination of education and experience.
- Strong verbal and written communication skills.
- Excellent organizational and time management abilities.
- Proficiency in Microsoft Word and Excel.
- Ability to understand medical documentation, such as physician notes and pathology reports.
- Capacity to manage multiple projects simultaneously.
- Strict adherence to confidentiality standards.
- Positive customer service and teamwork orientation.
- Self-motivated and detail-oriented.
- Strong understanding of GCP/ICH guidelines and FDA regulations.
- Analytical and problem-solving skills.
- Comfort with standard math operations and data interpretation.
- Physical ability to sit, stand, walk, and lift up to 25 lbs.
- Willingness to travel as required.
Nice To Haves
- Medical terminology and health information management experience.
Responsibilities
- Manage site data for all West Clinic study subjects.
- Complete electronic and paper CRFs using scanned source documents or direct EMR access.
- Generate and follow up on queries for missing information, contacting sites every 7 days until resolved.
- Schedule and oversee sponsor monitoring visits.
- Review CRF entries for accuracy before monitoring visits.
- Communicate with site personnel to resolve outstanding issues.
- Meet with monitors during visits to complete CRF corrections.
- Maintain subject screening and enrollment logs as directed.
- Prepare for potential study audits.
- Serve as liaison between the coordinator, monitor, and regulatory affairs.
- Attend investigator meetings and sponsor/CRO visits as needed.
- Participate in internal and external meetings, including with project management and regulatory teams.
- Develop timelines based on project priorities.
- Promote professionalism and maintain confidentiality.
- Collaborate with internal and external stakeholders.
- Perform other duties as assigned.
Benefits
- Ongoing training, educational resources, and growth opportunities.
- Comprehensive benefits package.
- No nights, weekends, or holidays.
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What This Job Offers
Job Type
Full-time
