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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site management and start-up activities, including site qualification and activation, while ensuring compliance with Good Clinical Practice and regulatory requirements. Strong relationship-building skills with stakeholders and effective communication abilities are essential for successful site coordination and issue resolution.
Highest-signal resume keywords
Site Management ExperienceGood Clinical Practice KnowledgeSite Activation ActivitiesEffective Communication SkillsRelationship Building
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site QualificationSite ActivationProtocol FeasibilityRegulatory RequirementsInvestigational Product ManagementSite Initiation TrainingSite MonitoringStudy ManagementQuality AssuranceCross-Functional Relationship Management
Soft Skills
Interpersonal SkillsNetworking SkillsAdaptabilityProblem-SolvingPresentation Skills
Tools & Technologies
Clinical Trial Management SystemsDocumentation SystemsCommunication Platforms
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
ICH GuidelinesGCP ComplianceSite Initiation VisitCountry RequirementsClinical Research Associate
About the role
Key responsibilities & impact- Serve as a crucial liaison for investigative sites throughout a study's lifecycle
- Qualify and activate assigned sites and deploy client site strategies
- Support country and site selection activities, including site list review and site qualification
- Provide country/regional input on protocol feasibility, standard of care, and medical practices
- Conduct site start-up activities, including site qualification, activation checklists, ICF finalization, and SIV as applicable
- Coordinate site initiation training and complete documentation and systems required for activation
- Ensure follow-up completion after site qualification visits and SIV to prepare sites for FSFV
- Partner with CRAs to ensure site monitoring readiness and enrollment delivery
- Build and maintain relationships with site organizations, strategic partners, investigators, and site staff
- Coordinate communications and resolution of escalated site issues, including vendor, contract, and payment issues
- Manage investigational product and ancillary supply strategies and country requirements
- Support recruitment planning and delivery consistent with global, country, and local targets
- Partner with regulatory authorities and study start-up teams to complete country/local registries
- Provide site recommendations and local intelligence based on country, site, process, and performance knowledge
- Support study management with local import/export requirements for investigational products and supplies
- Review site reports and related issues
- Assure quality and consistency in monitoring delivery
- Support CRA-investigator relationships and escalate training or compliance concerns
- Complete required training, timesheets, expense reports, and CV updates
- Comply with Parexel processes, ICH-GCPs, and applicable requirements
Requirements
What you’ll need- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Good communication, presentation, and interpersonal skills
- Ability to manage required travel
- Demonstrated networking and relationship building skills
- Demonstrated ability to manage cross functional relationships
- Ability to communicate effectively and appropriately with internal & external stakeholders
- Ability to adapt to changing technologies and processes
- Knowledge of country requirements for GCP that may be different to those of client procedures
- Effectively overcoming barriers encountered during the implementation of new processes and systems
- Identifies and builds effective relationships with investigator site staff and other stakeholders
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Able to manage issues that are escalated by site staff in a way that meets the needs of both the client and the site staff
- Demonstrated experience in site management with prior experience as a CRA
- Demonstrated experience in start-up activities through site activation
- Demonstrated experience in conduct and close out activities
- Demonstrated knowledge of quality and regulatory requirements in applicable countries
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)
- English is required; proficiency in local language preferred
