Clinical Development Specialist

Quest Diagnostics - San Juan Capistrano, CA

Full-time

San Juan Capistrano, CA

Ambulatory Health Care Services

About the position

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.

Responsibilities

• Develop study initiation and management plans with Clinical Development Management and Principal Investigators.
• Assist with assessing site/investigator interest and feasibility, site selection, initiation/training, and provisioning of study materials to study sites.
• Track study progress, adherence to protocol, data submission, deviations, and discrepancies.
• Communicate with sites on a regular basis, sending updates on current status of study enrollment and resolving study-related queries.
• Work with Biorepository staff to ensure efficient and accurate study sample management and relay information on sample transfer to/from analysis lab personnel.
• Provide sample handling expertise and guidance during project design and operation.
• Build, populate, and maintain study document folders.
• Proactively identify and communicate potential program risks to Clinical Development Management/PI and provide possible mitigation strategies.
• Work with data management to design Case Report Forms (CRFs) and resolve data discrepancies.
• Act as a research services manager for select sites and external vendors.
• Monitor routing and status of contracts and agreements.
• Assist in subject recruitment and conduct informed consenting as needed.
• Collaborate and coordinate activities with other Coordinators to ensure continuity of study management.
• Coordinate payments to study sites and vendors and subject reimbursements.
• Perform remote or on-site monitoring visits.
• Assist with and oversee efforts provided by third-party vendors such as CROs.
• Co-manage a study status database with other Coordinators.
• Assess resource demands and report needs to Clinical Development Management to assure timely achievement of program deliverables.
• Coordinate deidentification of Quest samples and transportation to external collaborators.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree preferably in health or life sciences.
• Three or more years of experience working as a clinical research study coordinator or a minimum of five years of clinical research experience.
• Working knowledge of Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines and/or Clinical Laboratory Improvement Amendments (CLIA).
• Current CITI training for Human Subjects Research or willingness to complete it.
• Effective written and verbal communication skills.
• Ability to set priorities and address high-priority tasks appropriately.
• Strong problem-solving skills and adaptability to learn novel approaches.
• Ability to drive innovation by embracing diversity and change.
• Outstanding organizational skills and ability to manage multiple projects simultaneously.
• Proficient in Microsoft Office.
• Fundamental knowledge of clinical and scientific research.