Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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 capabilities in documentation and communication.
Highest-signal resume keywords
Clinical Research CoordinationICH/GCP Guidelines KnowledgeContract NegotiationSite Activation ManagementRegulatory Compliance
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 regulatory compliance
- Support IRB/IEC renewals, PI changes, and document expirations
- Participate in study team meetings and develop action plans for site-level risks and issues
- Support CRA teams with site initiation visit preparation, vendors, 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 research sites
- Maintain high-quality filing systems and an audit-ready Trial Master File
- Track start-up progress and ensure sites meet requirements and deadlines
- Maintain system compliance and audit readiness
- Ensure timely delivery to investigative sites within scope and budget
- Perform Case Report Form review and data validation against source documentation
- Monitor protocol deviations and Serious Adverse Event reporting
- Perform country and site informed consent form review and customization
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), 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 and a minimum of 5 years' work experience in clinical research may be considered in lieu of the above requirement
- Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations
- Fluent in 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 other 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
- Understanding of clinical trial and research regulations and guidelines
- Ability to identify and resolve start-up process issues
- Ability to negotiate contracts and budgets effectively with research sites
Benefits
Comp & perks- Remote-based work required with possible office presence depending on location
- Limited travel, only for training
- Equal employment opportunity and accommodations support
ATS Keywords
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Hard Skills
Clinical Study Start-UpSite-Level Activity ManagementFeasibility Survey CollectionEssential Document Quality ReviewCase Report Form ReviewData ValidationProtocol Deviation MonitoringInformed Consent Form CustomizationBudget NegotiationAudit-Ready Trial Master File Maintenance
Soft Skills
Problem SolvingMultitaskingEffective CommunicationIssue ResolutionTeam Collaboration
Certifications & Qualifications
Nursing CertificationMedical Technology CertificationLaboratory Technology Certification
Industry Keywords
IRB/IEC RegulationsRegulatory Authorities LiaisonClinical Trial RegulationsResearch Protocol RequirementsSite Initiation Visit Preparation