Site Operations Specialist

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 meetings

Responsible 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 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

Technical 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 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

Capabilities

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 needed

Ability 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 ori