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Fortrea

. Coordinate site-level activities throughout clinical study start-up and potentially closeout .

Posted 10/5/2026full-timeRemote • IndiaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in coordinating clinical study activities, managing site-level compliance, and conducting contract negotiations. Proficient in ICH/GCP guidelines and regulatory requirements, with strong communication skills in both local language and English.

Highest-signal resume keywords

Clinical Research CoordinationICH/GCP Guidelines KnowledgeContract NegotiationRegulatory Compliance ManagementSite Activation Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite ActivationFeasibility SurveysSource Data ValidationCRF ReviewProtocol Deviation MonitoringBudget NegotiationRegulatory SubmissionsInformed Consent Form CustomizationTrial Master File Management

Soft Skills

Issue ResolutionMultitaskingDeadline ManagementCommunicationTeam Collaboration

Tools & Technologies

Fortrea SystemTrial Master File Systems

Certifications & Qualifications

University/College Degree in Life ScienceCertification in Allied Health Profession

Industry Keywords

IRB/IEC RegulationsResearch Protocol RequirementsClinical Trial RegulationsRegulatory Authorities LiaisonInvestigator Start-Up Documents

About the role

Key responsibilities & impact

Coordinate site-level activities throughout clinical study start-up and potentially closeout
Serve as the primary point of contact for investigative sites
Identify and assess potential research sites
Conduct initial site outreach and collect confidentiality agreements and feasibility surveys
Manage site-level activities, resolve issues, and support study timelines and compliance
Conduct remote pre-study visits and complete follow-up documentation
Support customization and translation of informed consent forms and patient-facing materials
Collect, track, and quality-review essential documents for site activation and ongoing regulatory compliance
Support IRB/IEC renewals, PI changes, and document expiration management
Participate in study team meetings and develop action plans for site-level risks and issues
Support CRA teams in preparing site initiation visits and coordinating supplies, access, and documents
Submit to and liaise with IRB/IEC, third bodies, and regulatory authorities
Conduct initial and amended contract and budget negotiations with sites
Maintain filing quality in applicable systems and keep the Trial Master File audit ready
Track start-up progress and ensure sites meet requirements and deadlines
Maintain Fortrea system compliance and audit readiness
Ensure timely delivery to investigative sites within scope and budget
Perform CRF review, source data validation, and monitoring of protocol deviations and SAE reporting
Perform country and site informed consent form review and customization
Perform other assigned duties

Requirements

What you’ll need

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution, or 2–3 years' work experience in clinical research
Relevant and equivalent experience may be considered in lieu of educational requirements
High School Diploma or equivalent plus a minimum of 5 years' work experience in clinical research may be considered
Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations
Fluent in the local official language and English, written and verbal
At least one year of experience in a related field
Basic knowledge of ICH/GCP, RA, IRB/IEC, and applicable regulations/guidelines
Familiarity with investigator start-up documents and contract/budget negotiation processes
Understanding of research protocol requirements
Ability to manage multiple tasks and deadlines simultaneously
Understanding of clinical trial and research regulations and guidelines
Ability to identify and resolve issues during the start-up process
Ability to negotiate contracts and budgets effectively with research sites

Benefits

Comp & perks

Remote-based work
Limited travel, restricted to training only
Possible office presence depending on location
EEO and accommodations support