Senior Clinical Research Associate - FSP

Parexel•Quebec, QC

5d•Remote

About The Position

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ 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.

Requirements

Candidates must be located in Montreal.
4-5 years recent Oncology experience.
Able to speak and write French.
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.
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.
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.
Ability to travel nationally/internationally as required.
Valid driving license per country requirements, as applicable.

Nice To Haves

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.
Familiar with risk-based monitoring approach including remote monitoring.
Good cultural awareness.

Responsibilities

Has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s).
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.
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.
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.
Performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel.
May take on additional responsibilities that include additional tasks associated with LSAD.