Senior Clinical Research Associate - FSP

We are looking to fill a Senior Clinical Research position working as a full-time employee of Parexel FSP on long-term assignment remote for one of our clients. Candidates must be located in Montreal have 4-5 years recent Oncology experience and able to speak and write French. This position will offer full benefits, sick time, paid holidays, and paid time off. This position does not offer any sponsorship.

Job Purpose:

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel.

A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.

Skills (Essential):

• Excellent attention to detail.

• Good written and verbal communication skills.

• Good collaboration and interpersonal skills.

• Good negotiation skills.

• Proficient in written and spoken English language required.

• Fluency in local language(s) required.

Skills (Desirable):

• Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Knowledge and Experience (Essential):

• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Good medical knowledge and ability to learn relevant Client Therapeutic Areas.

• Basic understanding of the drug development process.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Knowledge and Experience (Desirable):

• Familiar with risk-based monitoring approach including remote monitoring.

• Good cultural awareness.

Education:

• Bachelor’s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

Other:

• Ability to travel nationally/internationally as required.

• Valid driving license per country requirements, as applicable