Senior Clinical Research Associate

Job Description

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Job Responsibility

Local responsibility for the delivery of the studies at allocated sites
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
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

Requirements

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
ability to travel nationally/internationally as required
valid driving license per country requirements

Nice to have

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

What we offer

Full benefits
sick time
paid holidays
paid time off

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Senior Clinical Research Associate - FSP

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