Remote CRA: Site Monitoring & Trial Quality

Parexel

Dover (DE)

Remote

USD 70,000 - 95,000

Full time

5 days ago
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Job summary

Parexel is seeking a Clinical Research Associate (CRA) to manage investigator sites, conduct monitoring, and oversee site close-out for assigned trials. You will ensure patient safety, data integrity and regulatory compliance across GCP standards, coordinating with the Site Care Partner and study team.

The role requires at least 2 years of site monitoring experience, fluent English, and the ability to travel 60–80%. A life sciences degree is preferred.

Qualifications

  • Extensive knowledge of clinical trial methodologies, ICH/GCP and regulatory requirements.
  • Minimum 2 years of practical site monitoring experience.
  • Fluency in English and local country language(s).

Responsibilities

  • Ensure proper conduct of clinical trials per SMP, GCP and sponsor standards.
  • Manage site activation through database lock with timelines and quality.
  • Serve as primary contact for investigator sites; escalate to SCP when needed.
  • Coordinate information flow between study team, vendors and sites.
  • Provide investigator site development and training to ensure protocol compliance.
  • Attend investigator meetings; support enrollment and recruitment efforts.
  • Conduct onsite or remote monitoring; ensure QA and protocol adherence.
  • Monitor AEs/SAEs; collaborate with Drug Safety; follow-up as required.
  • Submit TMF documents, site reports and required updates within deadlines.
  • Identify and resolve site issues; implement corrective actions.
  • Close-out site activities and ensure compliance with data handling policies.

Skills

Clinical trial principles
FDA & regulatory knowledge
English fluency
Travel readiness
Driver's license

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking a Clinical Research Associate (CRA) to manage investigator sites, conduct monitoring, and oversee site close-out for assigned trials. You will ensure patient safety, data integrity and regulatory compliance across GCP standards, coordinating with the Site Care Partner and study team.

The role requires at least 2 years of site monitoring experience, fluent English, and the ability to travel 60–80%. A life sciences degree is preferred.

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