Start-Up Specialist

Fortrea

. Serve as primary contact with investigative sites during site start-up and maintenance activities .

Posted 10/19/2026full-timeDurham • North Carolina • United StatesJuniorMid-Level💰 $50,000 - $70,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory processes, including ICH guidelines and IRB/IEC regulations, while effectively managing site start-up and maintenance activities. Proficient in document preparation, quality review, and communication with regulatory authorities and investigative sites.

Highest-signal resume keywords

Clinical Development ExperienceICH Guidelines KnowledgeRegulatory Authority InteractionSite Start-Up Document FamiliarityContract Negotiation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationQuality ReviewBudget TrackingRisk ManagementClinical Research Protocol Understanding

Soft Skills

Effective CommunicationMentoring and TrainingProblem-SolvingTeam Collaboration

Tools & Technologies

In-House SoftwareOff-the-Shelf Software

Certifications & Qualifications

University/College Degree in Life ScienceCertification in Allied Health Profession

Industry Keywords

Clinical ResearchSite Activation StrategyEC/IRB SubmissionAudit ReadinessOperational Project Teams

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as primary contact with investigative sites during site start-up and maintenance activities
Collect, organize, track, quality-review, format, and compile investigator and essential study documents
Ensure EC/IRB/Third body/Regulatory Authority and local applications are submitted within agreed timelines
Provide guidance to EC/IRB/Third body/Regulatory Authorities regarding requirements
Maintain awareness of regulatory legislation, guidance, practice, ICH/GCP, SOPs, and quality standards
Prepare country application forms, cover letters, routine submissions, INDs/CTAs, and other regulatory documents
Liaise with regulatory authorities, internal teams, external vendors, investigative sites, and project teams
Review final submission documents and ensure documentation meets sponsor and regulatory requirements
Track start-up and maintenance activities, budgets, deliverables, risks, out-of-scope hours, and timelines
Escalate study issues and risks appropriately and promptly
Ensure high-quality documents are filed and systems are updated for audit readiness
Participate in team and project meetings
Assist with Site Activation strategy and provide projections and timelines
Review and customize country- and site-specific informed consent forms
Support negotiation and tracking of site contracts and budgets
Mentor and train new hires and less-experienced colleagues when appropriate
Perform other assigned duties

Requirements

What you’ll need

Residing within the U.S.
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
Relevant and equivalent experience may be considered in lieu of educational requirements
High School Diploma or equivalent plus a minimum of 2 years' work experience in clinical research may be accepted in lieu of the degree/certification requirement
Minimum of 2 years of experience in clinical development or start-up/regulatory process
Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations
Familiarity with investigator start-up documents and contract/budget negotiation processes
Previous interaction with operational project teams and investigative sites
Understanding of research protocol requirements and ability to communicate and educate others about them
Ability to work in a fast-paced, constantly changing, technology-based environment
Ability to sit for extended periods and operate a vehicle safely
Ability to perform repetitive hand movements and occasional crouching, stooping, bending, and twisting
Ability to use in-house and off-the-shelf computer software
Ability to lift and carry 15–20 lbs
Regular and consistent attendance; varied hours may be required

Benefits

Comp & perks

Full-time employment
Remote work designation
Ongoing application acceptance
EEO and accommodations support