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Senior Clinical Research Associate – Onco/CNS
Worldwide Clinical Trials. Lead site qualification, initiation, interim monitoring, management, and close-out activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research principles, regulatory compliance, and site management, with a strong focus on patient safety and data integrity. Proficient in leading teams, developing monitoring plans, and mentoring colleagues while ensuring adherence to protocols and regulatory requirements.
Highest-signal resume keywords
Clinical Research Associate (CRA) ExperienceFDA And EU Regulations KnowledgeTherapeutic-Area ExpertiseMicrosoft Office ProficiencyElectronic Data Capture (EDC) Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Research PrinciplesProtocol AdherenceSource Document VerificationCRF ReviewQuery ResolutionMonitoring Plan DevelopmentInvestigator Site File MaintenanceRegulatory DocumentationInvestigational Product AccountabilityTrial Master File Management
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsTime ManagementProblem-Solving Skills
Tools & Technologies
Microsoft OfficeIxRSElectronic Data Capture (EDC) Systems
Certifications & Qualifications
MDPharmacy QualificationPharmDPhDEquivalent Pharmacy Degree
Industry Keywords
Clinical MonitoringInformed ConsentSafety-Information ReviewRegulatory RequirementsICH GuidelinesSOPsSite PerformanceStudy MilestonesClinical TrialsPatient Safety
About the role
Key responsibilities & impact- Lead site qualification, initiation, interim monitoring, management, and close-out activities
- Protect patient safety and data integrity through informed consent and safety-information review, source document verification, CRF review, and query resolution
- Guide sites on protocol adherence, Investigator Site File maintenance, regulatory and ethics documentation, investigational product accountability, and ongoing study requirements
- Coordinate CRAs as a Lead CRA on global studies
- Mentor and train less experienced colleagues and site staff, including accompanied visits
- Partner with Project Management and study teams on deliverables, study milestones, site performance, and monitoring activities
- Develop monitoring plans, study-specific tools, templates, and training materials
- Review site visit reports and provide feedback and edits
- Ensure site documentation is maintained for filing in the Trial Master File
- Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, and protocol and CRF design
Requirements
What you’ll need- MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with at least 3 years’ CRA experience; or minimum four-year college curriculum in a relevant science with at least 5 years’ CRA experience; or two-year college curriculum or equivalent education/training, preferably nursing or equivalent life science degree, with at least 7 years’ CRA experience
- Extensive knowledge of clinical research principles and processes
- Thorough understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs
- Strong therapeutic-area expertise in two to three therapeutic areas
- Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills
- Ability to lead and motivate an assigned team when applicable
- Technical proficiency with Microsoft Office, IxRS, and electronic data capture (EDC) systems
- Valid current passport and driving licence
- Willingness to travel as required
- Proficiency in spoken and written English
- Fluency in the local languages of the countries under responsibility
Benefits
Comp & perks- Collaborative and inclusive work environment
- Growth and learning opportunities
- Home-based work arrangement
- Opportunity to act as Lead CRA on global studies
- Mentoring and training opportunities
- Global study team collaboration