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Senior Clinical Research Associate – Oncology/Hematology
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 extensive knowledge of clinical research, GCP, FDA and EU regulations, and ICH Guidelines while effectively managing site qualification, monitoring, and close-out activities. Proficient in communication and leadership, with the ability to mentor teams and ensure adherence to protocols and regulatory requirements.
Highest-signal resume keywords
Clinical Research KnowledgeGCP ComplianceSite Management ExperienceTeam LeadershipElectronic Data Capture 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 Research Associate (CRA) ExperienceMonitoring Visit Report PreparationSource Document VerificationCRF ReviewData Query ResolutionInvestigator Site File ManagementClinical Monitoring Plan ContributionTherapeutic Area KnowledgeRegulatory Documentation MaintenanceStudy Tool Development
Soft Skills
Communication SkillsPlanning SkillsOrganizational SkillsInterpersonal SkillsProblem-Solving SkillsTime-Management Skills
Tools & Technologies
Microsoft OfficeIxRSElectronic Data Capture Systems
Certifications & Qualifications
MD or Pharmacy DegreePhD or Equivalent Pharmacy Qualification
Industry Keywords
GCPFDA RegulationsEU RegulationsICH GuidelinesClinical TrialsSite QualificationMonitoringInvestigator MeetingsSOPsFull-Service Monitoring
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead site qualification, initiation, interim monitoring, management, and close-out activities
- Protect patient safety and data quality through informed consent review, source document verification, CRF review, safety information oversight, and data query resolution
- Partner with study teams, Project Management, investigators, and site staff on deliverables, milestones, protocol adherence, and site performance
- Coordinate CRAs as a Lead CRA on global studies
- Provide mentoring, training, accompanied visits, and practical guidance to colleagues and site teams
- Maintain regulatory, ethics, site, and TMF documentation
- Manage study materials, Investigator Site Files, and investigational product accountability
- Prepare and review monitoring visit reports
- Contribute to Clinical Monitoring Plans, study tools, protocols, CRFs, training, investigator meetings, and bid defenses
- Communicate with sites and study stakeholders and resolve issues throughout the study lifecycle
- Travel to investigative sites approximately 6–8 days per month
Requirements
What you’ll need- MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent Pharmacy qualification) with at least 3 years of CRA experience; or four-year degree in medical, biological, physical, health, pharmacy, or another related science with at least 5 years of CRA experience; or two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience
- Extensive knowledge of clinical research, GCP, FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, SOPs, monitoring, and site management activities
- Strong therapeutic-area knowledge and thorough understanding of two to three therapeutic areas
- Communication, planning, organization, interpersonal, problem-solving, and time-management skills
- Ability to lead and motivate an assigned team where applicable
- Proficiency with Microsoft Office, IxRS, and electronic data capture systems
- Valid current passport and driving licence
- Willingness to travel
- Fluency in the local languages of the countries under responsibility
- Proficiency in spoken and written English
- Experience in full-service monitoring preferred
Benefits
Comp & perks- Collaborative and inclusive work environment
- Growth and career development opportunities
- Learning opportunities
- Home-based work arrangement
- Opportunity to contribute as a Lead CRA on global studies
- Mentoring and guidance opportunities
- Global study team collaboration