Clinical Research Associate II

2 days ago

Québec, Quebec, Canada Syneos Health Full time
Job Title: Senior Clinical Research Associate

Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Job Responsibilities:
  • Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
  • Verify informed consent processes and maintain confidentiality of subject/patient data.
  • Assess site processes, conduct source document reviews, and verify clinical data accuracy.
  • Apply query resolution techniques and provide guidance to site staff.
  • Utilize hardware and software to support clinical study data review and capture.
  • Verify site compliance with electronic data capture requirements.
  • Perform investigational product inventory, reconciliation, and reviews.
  • Document activities and support subject/patient recruitment, retention, and awareness strategies.
  • Manage site-level activities and communicate with project site personnel.
Qualifications:
  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
About Syneos Health:

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

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