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Clinical Research Associate 1

Employer
ICON GSS - APAC
Location
India
Salary
Competitive
Start date
4 Oct 2022
Closing date
2 Nov 2022

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are
conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory
requirements.

  • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  • Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
  • Provides regular site status information to team members, trial management, and updates trial management tools
  • Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
  • Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  • Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
  • Performs essential document site file reconciliation
  • Performs source document verification and query resolution
  • Assesses IP accountability, dispensation, and compliance at the investigative sites
  • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
  • Communicates with investigative sites
  • Updates applicable tracking systems
  • Ensures all required training is completed and documented


  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
  • Clinical research experience
  • Knowledge of ICH and local regulatory authority regulations regarding drug
    An advanced degree (e.g., M.S., M.B.A., PharmD, etc)

Company

ICON is the leading provider of Functional Service Provision (FSP) globally. Our team of operational, functional and therapeutic specialists offer a range of FSP models that can be customised to deliver the most efficient operating model for your organisation. We bring a suite of capabilities, expertise and technology to augment your operations, increase R&D efficiencies and improve site engagement to access patient populations and deliver timelines and milestones. We have deployed FSP solutions across all major functions from clinical monitoring and project management through data management, statistical programming and beyond. ICON FSP experience 90+​ FSP partnerships 13,000+​ Employees 90+​ Countries Functional areas Our offering includes a range of globally scalable FSP solutions that are customised to provide support where and when you need it. We have significant experience in providing bespoke FSP solutions, particularly in: Study start-up Project Management Clinical monitoring Pharmacovigilance / Safety Clinical Supplies Management Data management Biostatistics and programming Contracts management Investigator payments Clinical vendor management & category management Medical writing Medical affairs Regulatory affairs Regulatory publishing

Find Us
Website
Location
Central Square
Suite 1701
323 Castlereagh St
Haymarket
NSW
2000 Australia
Australia
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