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Senior Clinical Research Associate
ClinChoiceSenior Clinical Research Associate managing oncology and complex clinical trials for ClinChoice, a global full-service CRO. Conducting site monitoring, data verification, safety reporting and study closeout.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing clinical trials, including site management, monitoring, and compliance with GCP/ICH Guidelines. Proficient in training site staff and ensuring data quality control while effectively communicating with investigative sites.
Highest-signal resume keywords
Clinical Trial ManagementOn-Site Monitoring ActivitiesGCP/ICH Guidelines KnowledgeClinical Research ExperienceMicrosoft 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 OperationsData VerificationSource Data ReviewCase Report Form ReviewSafety Issue ReportingStudy Budget NegotiationCRF Design/DevelopmentTraining Material DevelopmentMonitoring Visit ReportingInvestigational Product Management
Soft Skills
CommunicationTrainingProblem-SolvingTeam Leadership
Industry Keywords
Clinical Research OrganizationOncology TrialsRespiratory TrialsComplex Clinical TrialsRegulatory RequirementsStudy Start-UpSite SelectionSite EvaluationAdverse Event ReportingInformed Consent Development
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage 2–3 clinical trials and site management activities
- Conduct study start-up, site selection, site evaluation, initiation, monitoring and closeout activities
- Keep current with scientific, regulatory and operational aspects relevant to assigned clinical projects
- Train site staff in study procedures
- Conduct periodic on-site and remote monitoring visits and complete monitoring visit reports
- Review Case Report Forms for accuracy, legibility, completeness and quality
- Perform source data verification and in-house clinical data review
- Resolve data queries in a timely manner
- Manage investigational products and trial materials, including storage, inventory, dispensing records, packaging, labelling and study files
- Coordinate safety issue reporting and follow-up for AEs, SAEs and SUSARs
- Conduct and report study termination and archiving activities
- Serve as the main contact for investigative sites
- Support the Clinical Research Division with clinical data quality control
- Escalate issues that may jeopardize assigned clinical projects
- Report study activities and submit relevant documents to the Head of Department
- Develop training materials and deliver training with the Training & Qualification Management Unit
- Assist with site study budget contract negotiation after appropriate training
- Assist with CRF design/development, CRF instructions and study file organization
- Support project submissions, submission requirements, timelines and informed consent development
- Guide and supervise CRA I staff
Requirements
What you’ll need- University Degree in scientific, medical or paramedical disciplines
- Previous experience working for a CRO is required
- At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate performing on-site monitoring activities
- Experience monitoring oncology, respiratory and complex clinical trials is required
- Strong knowledge of clinical trial operations, GCP/ICH Guidelines and applicable regulatory requirements
- Fluent in English and local language(s)
- Proficiency in Microsoft Office, including Word, Excel and Outlook
- Willingness to travel to investigative sites as needed
Benefits
Comp & perks- Permanent employment
- Fully remote position
- Continuous training and professional development
- Equal opportunity, diversity and inclusivity
- Opportunity to work on varied studies across pharmaceutical, biotechnology, medical device and consumer health clients