When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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
Come join us!
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
