Site Operations Specialist Position Available In Wake, North Carolina

Site Operations Specialist Science 37 – 2.8

Morrisville, NC Job Details Estimated:

$47K – $55.6K a year 13 hours ago Qualifications Clinical research Logistics English Google Cloud Platform Mid-level Microsoft Office Administrative experience Bachelor’s degree Continuous improvement Quality control Data entry Clinical trials Good Clinical Practice Associate’s degree Documentation review Communication skills Time management Full Job Description

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

Key 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 filing Track study start-up and close-out documentation to ensure compliance and timely completion Collaborate with study team to assist in finalizing study plans and timelines Utilize clinical systems and vendor portals (e.g., IWRS, IRB portals, central lab platforms) to monitor study progress and vendor activities Conduct quality checks of data queries and support distribution to sites Maintain accurate and complete clinical study documentation in compliance with GCP and company standards Assist with investigator meeting logistics and coordination Support investigator payment tracking and other clinical project planning activities Contribute to clinical dashboard updates and performance metric tracking Perform first-pass data entry, document scanning, and uploading to internal systems Link clinical documents (e.g., CRFs) and assist with e-filing Provide administrative support to front desk operations as needed Schedule participant visits and coordinate with recruitment and scheduling teams Support medical record acquisition and follow-up activities Assist in supply and logistics coordination for site readiness Perform additional administrative tasks and cross-functional support duties 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 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