Senior Clinical Research Associate - Remote Monitoring Lead

Parexel

Providence (RI)

On-site

USD 90,000 - 130,000

Full time

4 days ago
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Job summary

Parexel FSP is seeking a Senior Clinical Research Associate (Sr CRA) to join our US-based team. The Sr CRA will oversee site management, monitoring, and close-out of trials to ensure patient safety and data integrity, in line with GCP and client standards.

The role requires strong site relationship management, enrollment support, and collaboration with SCP and study teams. Significant travel (60-80%) within the region is expected, including potential international exposure.

Qualifications

  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
  • Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
  • 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. May require some international travel and some weekend travel
  • Valid driver’s license and passport required

Responsibilities

  • Oversee monitoring of assigned investigator sites to ensure TPM and client standards are met.
  • Manage site activation through database lock with timelines and quality deliverables.
  • Serve as primary contact for investigator sites and coordinate with SCP to ensure site delivery.
  • Facilitate information flow among the study team, vendors and investigator sites.
  • Provide investigator site development and training to ensure protocol compliance and patient safety.
  • Attend investigator meetings and support enrollment at site level.
  • Conduct onsite/remote monitoring and close-out activities per SOPs.
  • Monitor AEs/SAEs and coordinate with Drug Safety for resolution.
  • Submit required reports and maintain TMF documentation.
  • Address investigator site issues and implement corrective actions.
  • Ensure oversight of investigational product handling at sites.
  • Support database release as needed.
  • May act as unblinded monitor when appropriate.

Skills

Clinical trial knowledge
GCP/ICH knowledge
Monitoring experience
Oncology experience
Global trials
English proficiency
Travel willingness
Driver's license & passport

Education

Bachelor’s degree in life sciences or related field

Job description

Parexel FSP is seeking a Senior Clinical Research Associate (Sr CRA) to join our US-based team. The Sr CRA will oversee site management, monitoring, and close-out of trials to ensure patient safety and data integrity, in line with GCP and client standards.

The role requires strong site relationship management, enrollment support, and collaboration with SCP and study teams. Significant travel (60-80%) within the region is expected, including potential international exposure.

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