Site Operations Specialist

About the role

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to-Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. The Site Operations Specialist plays a critical role in overall site enablement and the successful execution of clinical trials. This position supports a wide range of functions essential to the start-up, implementation, and conduct of Phase I, II, III, and IV clinical studies. Working cross-functionally, the Site Operations Specialist provides operational support to Site Operations Managers, Logistics Managers, Medical Record Supervisors, Recruitment Operations Managers, Scheduling Logistics Managers, Clinical Project Managers, and Clinical Research Coordinators. Key responsibilities include supporting study start-up activities, maintaining and tracking clinical budget data, assisting with medical record acquisition and follow-up, coordinating logistics and visit scheduling, and contributing to the upkeep of clinical dashboards, metrics, and multi-system administration. This role is also responsible for data entry and ensuring accurate tracking and filing of essential documents within the Investigator Site File. As a foundational member of the clinical operations team, the Site Operations Specialist ensures operational readiness and efficiency across departments, making this role indispensable to the broader success of site activation and trial delivery.

Responsibilities

• Drafts agendas and minutes for internal and/or external Study Team meetings
• Responsible for maintaining key study trackers, including but not limited to Study Contacts Lists, Study Question and Answer Logs, Site Budgets Log, clinical site contracts tracker, medical record status, and participant trackers
• Assists in creating and updating Investigator Site Files, including any e-filing or printing of required study documents
• Tracks required documentation for study start-up and close out
• Assists in tracking and finalizing study plans as requested by study team
• Assists in vendor management, including the efficient use of web tools such as IWRS, IRB web portals and central lab web portals to track the progress of studies and to ensure the studies are running smoothly
• Reviews data queries for accuracy and consistency prior to distribution to clinical sites
• Maintains complete and accurate clinical study documentation
• Represents Science 37 in a professional manner; establishes and maintains good relationships with investigators and all other study personnel
• Assists with coordinating Investigator Meeting attendees and items with Sponsor(s)
• Performs additional study related functions as required, e.g., preparation of and tracking payments to investigators, and participation in clinical project planning
• Supports the maintenance of the clinical dashboard
• Performs first pass data entry (if required)
• Links CRFs to any Data Clarifications Forms/information (if paper)
• Files/uploads documents after scanning
• Attends Staff Meeting as needed
• Supports clinical documents filing
• Supports Logistics
• Supports Medical Record Acquisition/follow up
• Supports front desk office staff as needed
• Supports scheduling of participant visits
• Other tasks as assigned

Skills

• Clinical Research Knowledge: Understanding of clinical trial phases (I–IV), GCP (Good Clinical Practice), and basic regulatory requirements
• Familiarity with clinical trial documents and workflows (e.g., ISF, CRFs, ICFs)
• Data and Document Management: Experience with eTMF systems and document control; Ability to manage and organize large volumes of trial documentation; Skilled in accurate data entry and quality control
• Clinical Systems Proficiency: Comfortable using CTMS, IWRS/IRT systems, and vendor portals (e.g., IRB, central lab) a plus; Proficient in Microsoft Office and Google Applications; Experience with dashboards or reporting tools is a plus
• Scheduling and Logistics Coordination: Experience supporting scheduling of patient visits and managing site logistics is a plus; Ability to coordinate across multiple teams and timelines
• Attention to Detail