Senior Clinical Research Associate – FSP

Parexel

. Ensure proper conduct of clinical trials according to the Study Monitoring Plan, applicable laws, GCP, and client standards .

Posted 11/6/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations, with a strong focus on Oncology and site monitoring. Capable of managing clinical trial activities, ensuring compliance, and facilitating effective communication among study teams and investigator sites.

Highest-signal resume keywords

Clinical Trial MonitoringICH/GCP ComplianceOncology ExperienceRegulatory KnowledgeEffective Communication

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

Clinical Trial MethodologiesData Acquisition and CleaningProtocol DesignRisk ManagementAdverse Event Monitoring

Soft Skills

Team CollaborationInfluencing SkillsCoaching and TrainingProblem SolvingVerbal and Written Communication

Tools & Technologies

TMF DocumentationStudy Monitoring PlanDatabase Management

Industry Keywords

Clinical ResearchOncologyFDA RegulationsGlobal Clinical TrialsPatient Safety

About the role

Key responsibilities & impact

Ensure proper conduct of clinical trials according to the Study Monitoring Plan, applicable laws, GCP, and client standards
Manage clinical trial activities at assigned investigator sites from site activation through database lock
Serve as primary point of contact for assigned investigator sites
Facilitate information flow among study team members, vendors, and investigator sites
Perform site development, coaching, and training with the SCP
Provide protocol training and address site staff questions
Attend investigator meetings and support enrollment and recruitment initiatives
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
Submit required reports, TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics
Maintain product, protocol, and therapy-area knowledge
Support patient safety, eligibility, and clinical guidance to investigators
Drive quality-event remediation and audit CAPA activities when applicable
Partner with SCP, Country Study Operations Manager, and other study team members
Report to the Director of Clinical Site Operations or Director of Site Management and Monitoring
May mentor Clinical Research Associates
Complete required training, timesheets, expense reports, and CV updates
Comply with Parexel processes, ICH-GCP, and applicable requirements

Requirements

What you’ll need

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required; some international and weekend travel may be required
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of monitoring, data acquisition and cleaning, and reporting
Demonstrated knowledge of disease and technical areas related to clinical studies
Ability to support sponsor regulatory interactions/inspections
Knowledge of protocol design and feasibility assessment
Understanding of regional/country culture and medical practice
Ability to work in a matrix team environment and influence, lead, and work through others
Ability to evaluate, interpret, and present complex issues and data for risk management and mitigation
Effective verbal and written communication skills
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent