Site Operations Specialist

Site Operations SpecialistMorrisville, North Carolina (Onsite)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.Duties include but are not limited to:Drafts agendas and minutes for internal and/or external Study Team meetingsResponsible 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 update of Investigator Site Files, including any e-filling or printing of required study documentsTracks required documentation for study start-up and close outAssists in tracking and finalizing study plans as requested by study teamAssists 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 smoothlyReviews data queries for accuracy and consistency prior to distribution to clinical sitesMaintains complete and accurate clinical study documentationRepresents Science 37 in a professional manner; establishes and maintains good relationships with investigators and all other study personnelAssists 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 planningSupports the maintenance of the clinical dashboardPerforms first pass data entry (if required)Links CRFs to any Data Clarifications Forms/ information (if paper)Files/ uploads documents after scanningAttend Staff Meeting as neededSupports clinical documents filingSupports LogisticsSupport Medical Record Acquisition/follow upSupports front desk office staff as neededSupports scheduling of participant visitsOther tasks as assignedTechnical Skills:Clinical Research Knowledge Understanding of clinical trial phases (I–IV), GCP (Good Clinical Practice), and basic regulatory requirementsFamiliarity with clinical trial documents and workflows (e.g., ISF, CRFs, ICFs)Data and Document Management Experience with eTMF systems and document controlAbility to manage and organize large volumes of trial documentationSkilled in accurate data entry and quality controlClinical Systems Proficiency Comfortable using CTMS, IWRS/IRT systems, and vendor portals (e.g., IRB, central lab) a plusProficient in Microsoft Office and Google ApplicationsExperience with dashboards or reporting tools is a plusScheduling and Logistics Coordination Experience supporting scheduling of patient visits and managing site logistics is a plusAbility to coordinate across multiple teams and timelinesSoft Skills:Attention to Detail Ability to manage complex documentation with accuracy and consistencyVigilant in identifying errors or missing informationOrganizational Skills Excellent time management with the ability to prioritize multiple tasksStructured and systematic in tracking deadlines and deliverablesCommunication Skills Strong written and verbal communication for clear documentation and correspondenceProfessional demeanor when interacting with sponsors, sites, and internal teamsTeam Collaboration Works effectively within cross-functional teamsWilling to assist in multiple areas to meet site and study needsAdaptability and Initiative Able to pivot between tasks and handle shifting priorities in a dynamic environmentProactive in identifying ways to improve operational efficiencyCore Competencies:Accountability: Takes ownership of assigned tasks and delivers high-quality work with minimal oversightProblem-Solving: Can troubleshoot basic operational issues and escalate appropriatelyConfidentiality and Integrity: Handles sensitive patient and trial data with discretionCustomer Service Orientation: Maintains professionalism and responsiveness in support of clinical sites and participantsProcess-Oriented Mindset: Follows established protocols while contributing to continuous improvement effortsQualificationsThe following qualifications are preferred/or equivalent applicable experience:Associate's or Bachelor's degree in a life sciences, healthcare, or related field preferred1+ years of clinical research or administrative experience, preferably in a sponsor, CRO, or site settingStrong organizational and multitasking skills with high attention to detailProficiency in Microsoft Office Suite and familiarity with clinical trial systemsExcellent written and verbal communication skillsAbility to work both independently and collaboratively in a fast-paced environmentCommitment to maintaining confidentiality and compliance with regulatory standardsCapabilitiesRequired to be in the North Carolina office 5 days a week for 6 months, following approval, may move to rotation of 3 days a week in office.Up to 10% travel, as needed, for study visits, training, project team meetings, client presentations and other professional meetings/conferences as neededAbility to communicate in English (both verbal and written); fluency in other languages is a plus.May require extended or unusual work hours based on research requirements and business needs.