Field-Based Clinical Research Associate (Mid-Atlantic)

AstraZeneca plc

New York (NY)

On-site

USD 112,000 - 168,000

Full time

10 days ago

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Job summary

AstraZeneca plc seeks a Clinical Research Associate to oversee delivery of studies at allocated sites and act as the primary contact for study sites. This field-based role favors candidates residing in the Mid-Atlantic region, with travel nationally and internationally as required.

You will initiate, monitor, and close sites in accordance with ICH-GCP and AstraZeneca SOPs, maintain CTMS/ISF, and train site staff. Collaboration with LSAD, QA, and MSLs is essential for study success.

Qualifications

  • Bachelor's degree in Life Sciences or related field.
  • Minimum 3 years CRA or similar experience in pharma/ CRO.
  • Excellent knowledge of ICH-GCP; basic GMP/GDP knowledge.
  • Strong site monitoring, data management, and documentation skills.
  • Willingness to travel nationally and internationally.

Responsibilities

  • Contributes to investigator selection.
  • Supports start-up and regulatory maintenance activities (SQVs, regulatory documents, EC/IRB submissions).
  • Trains and advises investigators and site staff on trial matters (RbQM).
  • Ensures training completion and inspection readiness of sites.
  • Performs onsite and remote monitoring per Monitoring Plans.
  • Maintains CTMS/ISF and drug accountability; conducts SDR/SDV/CRF review.
  • Prepares monitoring visit reports and follow-up letters on time.
  • Escalates quality issues to Local Management and QA teams.

Skills

ICH-GCP knowledge
Regulatory knowledge
Study monitoring
Site management
Communication skills
Attention to detail
Travel readiness

Education

Bachelor's degree in Life Sciences

Tools

CTMS
eTMF familiarity

Job description

AstraZeneca plc seeks a Clinical Research Associate to oversee delivery of studies at allocated sites and act as the primary contact for study sites. This field-based role favors candidates residing in the Mid-Atlantic region, with travel nationally and internationally as required.

You will initiate, monitor, and close sites in accordance with ICH-GCP and AstraZeneca SOPs, maintain CTMS/ISF, and train site staff. Collaboration with LSAD, QA, and MSLs is essential for study success.

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