Clinical Research Associate – Oncology

Parexel

Clinical Research Associate managing oncology clinical trials for Parexel, improving health through clinical research. Act acting primary site contact and site manager with significant monitoring responsibilities.

Posted 7/13/2026full-timeRemote • District of Columbia, Florida, Maryland, Ohio, Pennsylvania, Tennessee, Texas, Virginia • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Clinical Site Management and Monitoring, with a strong understanding of GCP/ICH guidelines and regulatory compliance. Proven ability to build site relationships, manage site performance, and ensure data integrity throughout all phases of clinical trials.

Highest-signal resume keywords

Oncology Monitoring ExperienceClinical Research KnowledgeSite Management SkillsGood Documentation PracticesClinical Trial Management System

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Site MonitoringData AnalysisRegulatory Documentation ManagementClinical Trial Phases UnderstandingIndependent Professional Judgement

Soft Skills

Customer FocusProblem SolvingCommunication Skills

Tools & Technologies

MS OfficeClinical IT ApplicationsElectronic Trial Master File

Industry Keywords

Good Clinical PracticesInternational Conference on HarmonizationBiotechPharmaCRO

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
Gains an in-depth understanding of the study protocol and related procedures
Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
Participates and provides inputs on site selection and validation activities
Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased; Subjects’ right, safety and well-being are protected
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager
Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines
Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
Supports and/or leads audits/inspection activities as needed
Performs co-monitoring visits where appropriate

Requirements

What you’ll need

Minimum 2 years of direct on site monitoring experience in biotech/pharma/CRO organization
Oncology monitoring experience required
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
Hands on knowledge of Good Documentation Practices
Proven skills in Site Management including management of site performance and patient recruitment
Demonstrated high level of monitoring skill with independent professional judgement
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
Ability to understand and analyze data/metrics and act appropriately
Demonstrated high level of monitoring skill with independent professional judgement
Able to work highly independently across multiple protocols, sites, and therapy areas
Demonstrates commitment to Customer focus

Benefits

Comp & perks

Health insurance
Professional development opportunities