Remote Clinical Research Associate — Oncology & Site Management

Parexel

Augusta (ME)

Remote

USD 75,000 - 100,000

Full time

3 days ago
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Job summary

Parexel is seeking a Clinical Research Associate to act as the primary site contact and site manager across all phases of clinical studies. You will develop strong site relationships, perform site monitoring, and ensure compliance with ICH-GCP and sponsor SOPs.

Typical responsibilities include coordinating regulatory documentation, communicating with investigators, and managing data quality through CTMS/eTMF tools.

Qualifications

  • Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
  • Bachelor’s degree preferred with a strong emphasis in science and/or biology.

Responsibilities

  • Act as the primary site contact and site manager through all phases of a clinical study.
  • Coordinate and manage site monitoring activities to ensure data quality and patient safety.
  • Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out.
  • Communicate with investigators and site staff on protocol conduct, deviations, and audits/inspections.
  • Maintain and document activities in the trial management system and eTMF.

Skills

Site management
Monitoring visits
ICH-GCP
Regulatory documentation
Communication with Investigators
Data review & reporting

Education

Bachelor’s degree in science

Tools

CTMS
eTMF
Microsoft Office

Job description

Parexel is seeking a Clinical Research Associate to act as the primary site contact and site manager across all phases of clinical studies. You will develop strong site relationships, perform site monitoring, and ensure compliance with ICH-GCP and sponsor SOPs.

Typical responsibilities include coordinating regulatory documentation, communicating with investigators, and managing data quality through CTMS/eTMF tools.

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