Senior Clinical Research Associate – Oncology

Parexel

Senior 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.

Posted 7/9/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in site monitoring within CRO or pharmaceutical environments, with a strong focus on oncology studies. Proficient in ICH-GCP guidelines, clinical study management, and regulatory compliance, ensuring high-quality data and effective investigator support.

Highest-signal resume keywords

Oncology Monitoring ExperienceSite Monitoring ExperienceICH-GCP KnowledgeClinical Study ManagementAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site Quality Risk AssessmentData Query ResolutionStudy Drug HandlingRegulatory Inspection PreparationTraining and Support for Investigators

Soft Skills

Collaboration SkillsInterpersonal SkillsNegotiation SkillsWritten Communication SkillsVerbal Communication Skills

Industry Keywords

CROPharmaceuticalGMPGDPLife ScienceDrug Development ProcessTherapeutic AreasLocal RegulationsClinical TrialsStudy Management

Tech Stack

Tools & technologies

Google 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