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FSP CRA, Level II
Thermo Fisher Scientific. Perform and coordinate clinical monitoring and site management activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP and applicable regulations while effectively communicating with investigative sites and managing trial documentation.
Highest-signal resume keywords
Clinical Monitoring SkillsICH GCP UnderstandingRisk Based Monitoring ManagementCritical ThinkingMicrosoft Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Documentation ManagementSource Document ReviewData VerificationRoot Cause AnalysisProcess ImprovementTrial Status TrackingRegulatory ComplianceSite ManagementInventory ReviewAudit Readiness
Soft Skills
Effective Interpersonal SkillsGood Oral CommunicationAttention to DetailOrganizational SkillsFlexibility and Adaptability
Tools & Technologies
Clinical Trial Management Systems
Certifications & Qualifications
Bachelor's Degree in Life SciencesRegistered Nursing Certification
Industry Keywords
Clinical ResearchMedical TerminologyProtocol ComplianceInvestigational Product AssessmentSite InitiationTrial Close-Out
About the role
Key responsibilities & impact- Perform and coordinate clinical monitoring and site management activities
- Conduct remote and on-site visits to assess protocol and regulatory compliance
- Manage required clinical trial documentation and ensure audit readiness
- Monitor investigator sites using a risk-based monitoring approach
- Apply root cause analysis, critical thinking and problem-solving to identify process failures and corrective/preventive actions
- Ensure data accuracy through source document review, source data verification and case report form review
- Assess investigational product through inventory and records review
- Document observations and escalate deficiencies and issues through resolution
- Maintain contact with investigative sites between monitoring visits
- Conduct supervising tasks according to the approved monitoring plan
- Participate in investigator payments, meetings, site identification, site initiation, trial close-out and retrieval of trial materials
- Ensure crucial documents are complete according to ICH-GCP and applicable regulations
- Conduct on-site file reviews
- Provide trial status tracking and progress reports to the Clinical Team Manager
- Update clinical study systems, including Clinical Trial Management Systems
- Facilitate communication among investigative sites, the client company and the PPD project team
- Respond to company, client and regulatory requirements, audits and inspections
- Complete expense reports and timesheets
- Assist with project publications and tools and contribute to process improvement initiatives
Requirements
What you’ll need- Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
- Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship
- Valid driver's license where applicable
- Proven clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and medical terminology
- Understanding of ICH GCPs, applicable regulations and procedural documents
- Critical thinking, root cause analysis and problem-solving skills
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills
- Customer focus, listening skills and attention to detail
- Organizational and time management skills
- Effective interpersonal skills
- Flexibility and adaptability
- Ability to work independently or in a team
- Good digital literacy and solid knowledge of Microsoft Office
- Good English language and grammar skills
- Good presentation skills
Benefits
Comp & perks- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Employee benefits
- Career and development prospects
- Innovative, forward-thinking company culture
- Accessibility assistance or accommodation during the application process for job seekers with disabilities