POSITION OVERVIEW
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 AND RESPONSIBILITIES
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 toStudy 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 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 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 scanning Attend Staff Meeting as needed Supports clinical documents filing Supports LogisticsSupport Medical Record Acquisition/follow upSupports front desk office staff as neededSupports scheduling of participant visitsOther tasks as assignedKey Responsibilities:
Support the coordination and documentation of internal and external study team meetings (e.g., draft agendas and meeting minutes)Maintain critical study trackers including but not limited to:- Study contact lists
- Site budgets and contracts tracker
- Medical record status
- Participant enrollment logs
- Study Q&A logs
Assist in the creation, maintenance, and organization of Investigator Site Files (ISF), including electronic and physical document filingTrack study start-up and close-out documentation to ensure compliance and timely completionCollaborate with study team to assist in finalizing study plans and timelinesUtilize clinical systems and vendor portals (e.g., IWRS, IRB portals, central lab platforms) to monitor study progress and vendor activitiesConduct quality checks of data queries and support distribution to sitesMaintain accurate and complete clinical study documentation in compliance with GCP and company standardsAssist with investigator meeting logistics and coordinationSupport investigator payment tracking and other clinical project planning activitiesContribute to clinical dashboard updates and performance metric trackingPerform first-pass data entry, document scanning, and uploading to internal systemsLink clinical documents (e.g., CRFs) and assist with e-filingProvide administrative support to front desk operations as neededSchedule participant visits and coordinate with recruitment and scheduling teamsSupport medical record acquisition and follow-up activitiesAssist in supply and logistics coordination for site readinessPerform additional administrative tasks and cross-functional support duties as assignedTechnical 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
Soft Skills:
Attention to Detail- Ability to manage complex documentation with accuracy and consistency
- Vigilant in identifying errors or missing information
Organizational Skills- Excellent time management with the ability to prioritize multiple tasks
- Structured and systematic in tracking deadlines and deliverables
Communication Skills- Strong written and verbal communication for clear documentation and correspondence
- Professional demeanor when interacting with sponsors, sites, and internal teams
Team Collaboration- Works effectively within cross-functional teams
- Willing to assist in multiple areas to meet site and study needs
Adaptability and Initiative- Able to pivot between tasks and handle shifting priorities in a dynamic environment
- Proactive in identifying ways to improve operational efficiency
Core Competencies:
- Accountability: Takes ownership of assigned tasks and delivers high-quality work with minimal oversight
- Problem-Solving: Can troubleshoot basic operational issues and escalate appropriately
- Confidentiality and Integrity: Handles sensitive patient and trial data with discretion
- Customer Service Orientation: Maintains professionalism and responsiveness in support of clinical sites and participants
- Process-Oriented Mindset: Follows established protocols while contributing to continuous improvement efforts
QUALIFICATIONS & SKILLS
Qualifications The 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 standardsCapabilities
Required 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. DIRECT REPORTS
No direct reports
BENEFITS
At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work that adds to your professional development.Science 37 is an equal opportunity/affirmative action employer.
All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.Submit your resume to apply!To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here
