Senior CRA – Oncology Trials & Site Monitoring

Parexel

Jackson (MS)

On-site

USD 85,000 - 120,000

Full time

5 days ago
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Job summary

Parexel is seeking a Senior Clinical Research Associate (Sr. CRA) in the United States with strong site monitoring experience. You will oversee investigator sites, ensure patient safety, and drive quality trial execution under GCP and sponsor standards.

You will manage site activation through closeout, mentor site staff, and collaborate with the SCP and study team to address risks and ensure timelines are met. Travel and regulatory knowledge are essential.

Qualifications

  • Minimum 3 years of site monitoring experience in clinical research, CRO or pharma
  • Oncology therapeutic experience preferred
  • Global clinical trial experience preferred
  • Extensive knowledge of ICH/GCP, FDA regulations and local country rules
  • Must be fluent in English and the local language(s)
  • Travel 60–80% within the area is required
  • Valid driver’s license and passport required

Responsibilities

  • Ensure proper conduct of trials per SMP, laws, GCP and sponsor standards
  • Manage site activation through database lock with timely, quality deliverables
  • Serve as primary contact for investigator sites coordinating with SCP
  • Facilitate information flow between study team, vendors and sites
  • Provide site personnel coaching and protocol training to ensure compliance
  • Attend investigator meetings and support enrollment progress and site activation
  • Work with SCP to define recruitment initiatives at site level
  • Conduct onsite and remote monitoring in line with SMP and SOPs
  • Monitor and follow up on AE/SAE reports with Drug Safety unit
  • Submit TMF, site reports, deviations and progress within required timelines
  • Identify and resolve site issues with CAPA when needed
  • Close-out activities and data query resolution within timelines
  • Oversee investigational product handling at sites; support database releases
  • May undertake unblinded monitoring when appropriate

Skills

Monitoring experience
Oncology experience
Global clinical trials
ICH/GCP knowledge
Fluent in English
Travel availability
Driver’s license & passport

Education

Bachelor’s degree in life sciences

Job description

Parexel is seeking a Senior Clinical Research Associate (Sr. CRA) in the United States with strong site monitoring experience. You will oversee investigator sites, ensure patient safety, and drive quality trial execution under GCP and sponsor standards.

You will manage site activation through closeout, mentor site staff, and collaborate with the SCP and study team to address risks and ensure timelines are met. Travel and regulatory knowledge are essential.

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