FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
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 principles, FDA and EU regulations, and ICH Guidelines while effectively leading site qualification and monitoring activities. Proficient in developing study-specific tools and providing mentorship to colleagues in a collaborative environment.
Highest-signal resume keywords
Clinical Research Associate (CRA) ExperienceKnowledge of FDA and EU RegulationsTherapeutic-Area ExpertiseProficiency with Electronic Data Capture (EDC) SystemsExcellent Communication Skills
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 PrinciplesSource Document VerificationProtocol AdherenceInvestigator Site File MaintenanceQuery ResolutionMonitoring Plan DevelopmentStudy-Specific Tools CreationTrial Master File ManagementRegulatory DocumentationInvestigational Product Accountability
Soft Skills
LeadershipMentoringOrganizational SkillsProblem-Solving SkillsTime Management
Tools & Technologies
Microsoft OfficeIxRSElectronic Data Capture (EDC) Systems
Certifications & Qualifications
MDPharmacy QualificationPhDMSPHPharmD
Industry Keywords
Clinical MonitoringSite QualificationInformed ConsentSafety InformationRegulatory RequirementsSOPsClinical TrialsStudy MilestonesInvestigator MeetingsLocal Language Proficiency
About the role
Key responsibilities & impact- Lead site qualification, initiation, interim monitoring, management, and close-out activities
- Protect patient safety and data integrity by reviewing informed consent and safety information
- Conduct source document verification and review CRFs
- Support timely query resolution
- Guide sites in 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
- Provide mentoring, training, accompanied visits, and practical guidance to less experienced colleagues and site staff
- Partner with Project Management and study teams to evaluate 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 relevant 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
- Travel to investigative sites approximately 8–10 days per month
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
- 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