Site Operations Specialist

Site Operations Specialist

Morrisville, 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:

1. Drafts agendas and minutes for internal and/or external Study Team meetings
2. 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.
3. Assists in creating and update of Investigator Site Files, including any e-filling or printing of required study documents
4. Tracks required documentation for study start-up and close out
5. Assists in tracking and finalizing study plans as requested by study team
6. 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
7. Reviews data queries for accuracy and consistency prior to distribution to clinical sites
8. Maintains complete and accurate clinical study documentation
9. Represents Science 37 in a professional manner; establishes and maintains good relationships with investigators and all other study personnel
10. Assists with coordinating Investigator Meeting attendees and items with Sponsor(s)
11. Performs additional study related functions as required, e.g., preparation of and tracking payments to investigators, and participation in clinical project planning
12. Supports the maintenance of the clinical dashboard
13. Performs first pass data entry (if required)
14. Links CRFs to any Data Clarifications Forms/ information (if paper)
15. Files/ uploads documents after scanning
16. Attend Staff Meeting as needed
17. Supports clinical documents filing
18. Supports Logistics
19. Support Medical Record Acquisition/follow up
20. Supports front desk office staff as needed
21. Supports scheduling of participant visits
22. Other tasks as assigned

Technical Skills:

1. Clinical Research Knowledge
   • Understanding of clinical trial phases (IIV), GCP (Good Clinical Practice), and basic regulatory requirements
   • Familiarity with clinical trial documents and workflows (e.g., ISF, CRFs, ICFs)
2. 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
3. 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
4. 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:

1. Attention to Detail
   • Ability to manage complex documentation with accuracy and consistency
   • Vigilant in identifying errors or missing information
2. Organizational Skills
   • Excellent time management with the ability to prioritize multiple tasks
   • Structured and systematic in tracking deadlines and deliverables
3. Communication Skills
   • Strong written and verbal communication for clear documentation and correspondence
   • Professional demeanor when interacting with sponsors, sites, and internal teams
4. Team Collaboration
   • Works effectively within cross-functional teams
   • Willing to assist in multiple areas to meet site and study needs
5. 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

The following qualifications are preferred/or equivalent applicable experience:

1. Associate's or Bachelor's degree in a life sciences, healthcare, or related field preferred
2. 1+ years of clinical research or administrative experience, preferably in a sponsor, CRO, or site setting
3. Strong organizational and multitasking skills with high attention to detail
4. Proficiency in Microsoft Office Suite and familiarity with clinical trial systems
5. Excellent written and verbal communication skills
6. Ability to work both independently and collaboratively in a fast-paced environment
7. Commitment to maintaining confidentiality and compliance with regulatory standards

Capabilities

1. 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.
2. Up to 10% travel, as needed, for study visits, training, project team meetings, client presentations and other professional meetings/conferences as needed
3. Ability to communicate in English (both verbal and written); fluency in other languages is a plus.
4. May require extended or unusual work hours based on research requirements and business needs.