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Senior Clinical Research Associate – Oncology
ParexelSenior Clinical Research Associate managing clinical oncology studies in the Midwest or Southwest US at Parexel. Engaging with study sites and ensuring compliance with international guidelines.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Contributes to the selection of potential investigators.
- Trains, supports and advises Investigators and site staff in study related matters.
- Confirms that site staff have completed and documented the required trainings appropriately.
- Actively participates in Local Study Team (LST) meetings.
- Drives performance at the sites and ensures timely resolution to study-related issues.
- Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
- Ensures data query resolution in a timely manner.
- Prepares for and collaborates with the activities associated with audits and regulatory inspections.
Requirements
What you’ll need- 5+ years of on site monitoring experience in a CRO or pharma organization
- 1+ years of oncology monitoring experience
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant client’s Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Excellent attention to details.
- Good written and verbal communication skills.
- Good collaboration and interpersonal skills.
- Good negotiation skills.
- Ability to travel nationally/internationally as required.
- Valid driving license
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Site Quality Risk AssessmentData Query ResolutionStudy Drug HandlingRegulatory Inspection PreparationTraining and Support for Investigators
Soft Skills
Collaboration SkillsInterpersonal SkillsNegotiation SkillsWritten Communication SkillsVerbal Communication Skills