Clinical Trial Associate

The Career Potential Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together. Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work. The Opportunity The Clinical Trial Associate, under the direction of the Sr. Manager, Clinical Operations, provides support for the creation and maintenance of paper and/or electronic clinical study records including the Trial Master File (TMF) with a focus on maintaining inspection readiness throughout the lifecycle of an individual clinical study or a clinical development program. The Clinical Trial Associate is an integral part of the study team in assuring that all clinical study documentation is handled appropriately and that assigned TMFs are complete, accurate, and timely. The Responsibilities Assist the Clinical Operations Manager(s)/Project Team to create/maintaining the TMF, ensuring tracking of essential study documents and periodic quality reviews to assure accuracy and completeness. Create, distribute, and manage TMF queries to internal and external TMF users Assists clinical trial managers (CTM) with preparation, handling, distribution, and tracking of clinical trial supplies and other study supplies Inform the Clinical Operations Manager/Project Team of any outstanding document(s). Provide support for inspection readiness by formatting, proofreading documents, and contributing to the establishment, maintenance, and quality control of the TMF Minor lifting, < 10 lbs. Must work from a regional-office location Perform other work-related duties as assigned. The Individual Minimum of an associate’s degree with 2 years of experience required. Bachelor's degree, Science background preferred. 1 year of prior experience in clinical research required Prefer experience managing or using a TMF system Strong Computer proficiency including MS Office suite required Must have a basic working knowledge of clinical operations including GCP guidelines Good knowledge of GDP (Good Document Practice) requirements Strict attention to detail and comfortable with repetitive work Ability to work independently and as a team member Travel- Less than 10% domestically required Key Working Relationships Internal: Clinical Affairs Management, Clinical Trial Managers, Clinical Research Associates, and Clinical Scientist External: Clinical Sites, External Clinical Research Organizations (CROs), Sample Vendors EOE/AA Disability/Veteran #LI-SC1