Quest Diagnostics - San Juan Capistrano, CA
posted 4 months ago
The Clinical Development Specialist at Quest Diagnostics plays a pivotal role in supporting clinical development research efforts in collaboration with Medical and Laboratory Directors, Clinical Development management, and external partners. This position is responsible for overseeing all operational aspects of clinical studies, which includes initiating studies, selecting and training sites, managing study documentation, monitoring study sites, resolving queries, and ensuring the smooth flow of data and specimens between sites. The role requires a proactive approach to track study progress, adherence to protocols, and communication with study sites to address any issues that arise during the study lifecycle. In addition to operational oversight, the Clinical Development Specialist will work closely with Biorepository staff to manage study samples effectively and provide guidance on sample handling. The specialist will also be involved in building and maintaining study document folders, identifying potential risks to the program, and collaborating with data management to design Case Report Forms (CRFs). This position requires strong organizational skills and the ability to manage multiple projects simultaneously while ensuring compliance with Good Clinical Practices (GCP) and other regulatory guidelines. The role is primarily remote or hybrid, allowing for flexibility in work arrangements, but the candidate must be located in the US. The Clinical Development Specialist will report directly to Clinical Development Management and will be expected to assist in subject recruitment, conduct informed consent processes, and coordinate payments to study sites and vendors. This position is integral to the success of clinical studies and requires a combination of scientific knowledge, project management skills, and effective communication abilities.