Parexel

Senior Clinical Research Associate

Parexel

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Contributes to the selection of potential investigators.
  • Responsible for study start-up and regulatory maintenance, including submissions to EC/IRB and Regulatory Authorities.
  • Trains and advises investigators and site staff in study related matters.
  • Ensures sites are inspection ready and maintains regular communication with study teams.
  • Initiates, monitors and closes study sites as per compliance.
  • Conducts monitoring visits, remote data checks, and Quality Risk Assessments during the study.
  • Ensures accurate and timely reporting of Serious Adverse Events.

Requirements

  • Excellent attention to detail.
  • Good written and verbal communication skills.
  • Good collaboration and interpersonal skills.
  • Good negotiation skills.
  • Proficient in written and spoken English language required.
  • Fluency in local language(s) required.
  • 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 Therapeutic Areas.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
  • Familiar with risk-based monitoring approach including remote monitoring.
  • Good cultural awareness.
  • Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs).
Benefits
  • Ability to travel nationally/internationally as required
  • Valid driving license per country requirements, as applicable
Applicant Tracking System Keywords

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

Hard Skills & Tools
monitoringregulatory maintenancedata managementQuality Risk Assessmentsstudy start-upSerious Adverse Events reportingdrug development processrisk-based monitoringstudy drug handlingclinical study management
Soft Skills
attention to detailwritten communicationverbal communicationcollaborationinterpersonal skillsnegotiation skillscultural awarenessability to learntrainingadvising
Certifications
Bachelor's degree in life science