Apply

Ready to go for it?

AI Apply speeds things up—apply directly if you prefer.

FREE ACCESS
5,000–10,000 jobs/day
Scoutfield Logo

See all jobs on Scoutfield

Search thousands of fresh jobs every day.

Discover
  • Fresh listings
  • Fast filters
  • No subscription required
Create a free account and start exploring right away.
Fortrea

Study Start-up Associate – Site Activation Specialist

Fortrea

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

Posted 9/15/2026full-timeRemote • IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submissions, including INDs and CTAs, while ensuring compliance with ICH guidelines and local regulations. Proficient in managing site start-up activities, mentoring team members, and maintaining effective communication with regulatory authorities and investigative sites.

Highest-signal resume keywords
Regulatory SubmissionsICH GuidelinesClinical Research ExperienceSite Start-Up ActivitiesContract Negotiation

ATS Keywords

Tailor your resume
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Regulatory Authority ComplianceClinical DevelopmentQuality ReviewDocument TrackingSubmission RequirementsResearch Protocol UnderstandingInvestigator Start-Up DocumentsBudget NegotiationPatient Informed Consent CustomizationCTIS Documentation
Soft Skills
CommunicationMentoringProblem-SolvingTeam CollaborationTraining
Certifications & Qualifications
University/College DegreeNursing CertificationMedical Technology CertificationLaboratory Technology Certification
Industry Keywords
Clinical ResearchIRB/IEC RegulationsRegulatory LegislationStart-Up ProcessOperational 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, quality-review, format, compile, and track investigator and essential documents
  • Ensure EC/IRB/Third body/Regulatory Authority and local applications are submitted within agreed timelines
  • Provide guidance to sites and authorities regarding submission requirements
  • Maintain awareness of regulatory legislation, guidance, practice, and current standards
  • Serve as local expert for project start-up activities in an assigned country or region
  • Prepare country application forms, cover letters, and routine regulatory submissions such as INDs/CTAs
  • Liaise with regulatory authorities, internal teams, external vendors, and investigative sites
  • Review final submission documents and ensure compliance with laws, guidelines, ICH/GCP, SOPs, and quality standards
  • Track start-up and maintenance activities, milestones, timelines, budgets, and deliverables
  • Prevent, identify, and escalate study issues and delivery risks
  • Customize patient informed consent forms for local requirements and protocol compliance
  • Support negotiation and tracking of site contracts and budgets when applicable
  • Upload and monitor submission documentation, notifications, and alerts in CTIS for EU studies
  • Participate in team and project meetings
  • Mentor and train new hires and less-experienced colleagues when appropriate

Requirements

What you’ll need
  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
  • 2 years' work experience in clinical research, clinical development, or start-up/regulatory process
  • Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations
  • 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 considered
  • Working knowledge of applicable regulations and guidelines
  • 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
  • Ability to communicate and educate others about research protocol requirements
  • Ability to work in a general office environment

Benefits

Comp & perks
  • Remote work arrangement
  • Full-time employment