Clinical Study Coordinator (6 Month Contract)
Company:Pattern Bioscience
Location:Florida, Maryland, Massachusetts, Missouri, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Washington, West Virginia
Languages:English
Seniority level:Junior, 1-3 years
Experience:1-3 years
Skills:
Project CoordinationCollaborationMicrosoft ExcelOrganizational skillsDocumentationComplianceResearchQuality AssuranceData management
Requirements:
Bachelor's degree in life sciences, biomedical engineering, medical technology, or a related field. 1-3 years of clinical research experience, ideally in IVD or medical device trials. Knowledge of FDA regulations, GCP, ISO 14155, and IVDR requirements for IVD clinical studies. Strong organizational skills. Ability to work independently and collaboratively. Clear and professional communication skills (oral and written). Comfortable traveling up to 50%, with potential peaks up to 75%.
Responsibilities:
Support day-to-day operations of IVD clinical studies, ensuring protocol compliance and regulatory adherence. Serve as a liaison for investigational sites, fostering strong relationships and providing timely support. Support site visits—including initiation, monitoring, and close-out—to ensure data integrity and protocol compliance. Oversee accurate and timely collection of study data and biological specimens. Contribute to the preparation of study reports and process documentation. Maintain essential documents and regulatory files in an audit-ready state. Ensure compliance with regulatory requirements. Support CRAs and the clinical team with clinical study documentation. Contribute to process improvements for clinical study operations.
