Clinical Trial Specialist

About Hope Biosciences Research Foundation Hope Biosciences Research Foundation (HBRF) is a nonprofit clinical research organization dedicated to advancing innovative therapies through clinical research. HBRF serves as both a clinical trial sponsor and an investigative research site, giving our team the unique opportunity to manage clinical studies from both perspectives. About the Role HBRF is seeking an experienced Clinical Trial Specialist (CTS) to join our clinical research team in Sugar Land, Texas. This is a uniquely hands-on and broad CTS position. Because HBRF both sponsors clinical trials and operates as an investigative research site, the Clinical Trial Specialist will have responsibilities spanning the full clinical trial lifecycle and both sponsor-and-site-level activities. The ideal candidate understands what it takes to move a clinical trial from start-up through enrollment, conduct, monitoring, and closeout—and is comfortable taking direct ownership of the regulatory and operational work required along the way. This is an excellent opportunity for an experienced clinical research professional who enjoys understanding and managing the entire clinical trial rather than working within a single functional silo. Key Responsibilities Manage assigned clinical trials from study start-up through closeout. Coordinate sponsor-level and investigative-site activities across multiple clinical studies. Prepare, coordinate, and maintain FDA regulatory submissions and IND-related documentation, including amendments, safety reports, annual reports, and other required submissions. Prepare and manage IRB submissions, amendments, continuing reviews, reportable events, and regulatory correspondence. Maintain sponsor-level Trial Master Files (TMFs) and site-level Investigator Site Files (ISFs) in an organized and inspection-ready state. Coordinate study start-up and site activation activities, including essential document collection, study training, and Site Initiation Visits (SIVs). Conduct and/or coordinate clinical trial monitoring activities, including qualification, initiation, interim monitoring, and closeout visits. Track study timelines, milestones, regulatory commitments, protocol deviations, safety-reporting requirements, essential documents, and outstanding study activities. Work closely with principal investigators, clinical research coordinators, data management, biostatistics, and other internal and external study stakeholders. Support the development and review of protocols, informed consent forms, study manuals, SOPs, and other clinical and regulatory documents. Ensure clinical trials are conducted in accordance with applicable FDA regulations, ICH-GCP guidelines, IRB requirements, study protocols, and organizational procedures. Support audits, regulatory inspections, and ongoing inspection-readiness activities. Maintain thorough study documentation and cross-training to ensure continuity across HBRF's clinical research programs. Qualifications Bachelor's degree in life sciences, nursing, clinical research, regulatory affairs, or a related discipline. 3+ years of progressively responsible clinical research experience; 5+ years preferred. Demonstrated experience with FDA-regulated interventional clinical trials. Strong working knowledge of FDA regulations, ICH-GCP, IRB requirements, TMF and ISF management, and clinical trial documentation. Experience with clinical trial start-up, study conduct, and closeout. Experience conducting or coordinating clinical trial monitoring activities. Demonstrated ability to independently manage multiple studies, priorities, and deadlines.Excellent organizational, written, and verbal communication skills. Strong attention to detail and follow-through. Ability to take ownership of responsibilities and work independently while collaborating closely with a multidisciplinary team. Preferred Experience Experience in several of the following areas is highly desirable: Both sponsor/CRO and investigative-site clinical research IND-sponsored clinical trials FDA and IRB regulatory submissions Clinical trial monitoring TMF and ISF management Sponsor-investigator or academically sponsored clinical research Cell therapy, biologics, regenerative medicine, or other complex interventional clinical trials Clinical research environments where individuals work across traditional functional boundaries Who We're Looking For The ideal candidate has developed breadth as well as depth in clinical research. Your current title may be Clinical Trial Manager, Clinical Research Associate, Regulatory Specialist, Senior CRA, or another clinical research role. What matters most is your ability to understand a clinical trial as a whole and independently take responsibility for moving it forward. We're looking for someone who recognizes what needs to happen next, takes ownership, communicates effectively, and follows through. The successful candidate will be highly organized, accountable, collaborative, adaptable, and comfortable being hands-on. #J-18808-Ljbffr