Clinical Research Associate – CRA II/Senior, Bilingual French/English
Job Description:
- Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports
- Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff
- Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol
- Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
- Evaluate the quality and integrity of the reported data, site efficacy and drug accountability
- Monitor completeness and quality of Regulatory Documentation and perform site document verification
Requirements:
- 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
- Bachelors or equivalent degree in biological science, pharmacy or other health related discipline
- Strong interpersonal, written, and verbal communication skills within a matrixed team
- Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight
- A client focused approach to work with a flexible attitude with respect to assignments and new learning
- The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s)
- An honest and ethical work approach
- Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word
- Fluency (written & spoken) in both English and French.
Benefits:
- World class technology and training
- Bonus incentive program
- Opportunity to work within multiple therapeutic areas
- Career advancement opportunities
