Site Operations Specialist

Science 37•Morrisville, NC

3d•Onsite

About The Position

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.

Requirements

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
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
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
Associate’s or Bachelor’s degree in a life sciences, healthcare, or related field preferred
1+ years of clinical research or administrative experience, preferably in a sponsor, CRO, or site setting
Strong organizational and multitasking skills with high attention to detail
Proficiency in Microsoft Office Suite and familiarity with clinical trial systems
Excellent written and verbal communication skills
Ability to work both independently and collaboratively in a fast-paced environment
Commitment to maintaining confidentiality and compliance with regulatory standards

Nice To Haves

Fluency in other languages is a plus.

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 update of Investigator Site Files, including any e-filling 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
Attend Staff Meeting as needed
Supports clinical documents filing
Supports Logistics
Support Medical Record Acquisition/follow up
Supports front desk office staff as needed
Supports scheduling of participant visits
Other tasks as assigned