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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced clinical monitoring and study site management skills, ensuring compliance with regulatory requirements and data integrity. Proficient in training and supervising staff while effectively managing clinical projects and communications.
Highest-signal resume keywords
Clinical Monitoring ExperienceRegulatory Requirements KnowledgeAdvanced Site Management SkillsSerious Adverse Event ReportingProject Coordination Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study Site MonitoringData Integrity VerificationCRF ReviewProtocol ComplianceFeasibility WorkQuality Control VisitsInvestigator Meeting PresentationsClinical Trial Report WritingBudget NegotiationProject Management
Soft Skills
Advanced Communication SkillsProblem-Solving AbilityTeam CollaborationTraining and MentoringWorkload Prioritization
Tools & Technologies
Data-Management SystemsComputer PackagesClinical Registries
Certifications & Qualifications
University or College Degree in Life ScienceNursing CertificationMedical or Laboratory Technology Certification
Industry Keywords
Clinical ResearchPharmaceutical IndustryCRO IndustryDrug Development ProcessSAE Reporting
About the role
Key responsibilities & impact- Perform all aspects of study site monitoring, including routine monitoring and clinical-site closeout
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and manage site activities according to project plans
- Ensure study staff receive materials and instructions to safely enroll patients
- Verify informed-consent procedures and protocol compliance to protect study patients
- Review source documents and ensure data integrity in CRFs and other data-collection tools
- Monitor missing or implausible data
- Perform monitoring tasks efficiently according to SOPs and guidelines, including economical travel-expense management
- Ensure site-level audit readiness
- Prepare accurate and timely trip reports
- Manage small projects under a Project Manager/Director
- Serve as lead monitor and assist with monitoring plans and trip-report review
- Review project progress and initiate actions to achieve objectives
- Organize and deliver Investigator Meeting presentations
- Participate in protocol and CRF development and clinical-trial report writing
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical-trial supplies and vendors
- Manage clinical registries according to project plans
- Conduct feasibility work and Quality Control visits when requested
- Recruit investigators and prepare EC submissions and regulatory-authority notifications
- Translate study documentation and organize meetings
- Negotiate study budgets and assist legal with agreements
- Track and follow up on SAE reporting, reports, narratives, and follow-up activities
- Perform CRF review, query generation, and query resolution in data-management systems
- Assist with training, mentoring, and development of new employees
- Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact when assigned
- Perform other duties assigned by management
Requirements
What you’ll need- University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered
- Relevant and equivalent experience may be considered in lieu of educational requirements
- Thorough knowledge of regulatory requirements, including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in the local office language and English, written and verbal
- Three years of Clinical Monitoring experience
- Full understanding of Serious Adverse Event (SAE) reporting, report production, narratives, and SAE follow-up
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good computer skills and working knowledge of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritize workload for self and team
- Ability to work within a project team and matrix environment
- Valid Driver's License
- One or more additional years of related experience preferred
- Local project coordination and/or project management experience preferred
Benefits
Comp & perks- Travel, including air travel, may be required and is an essential function of the job
- 60–80% overnight travel