Clinical Research Lead-Oncology
Eli Lilly and CompanyFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Canada
Candidates must have a Bachelor's degree in a related field or equivalent experience, with a strong preference for oncology experience and bilingual proficiency in French and English, particularly for candidates located in Quebec. A minimum of 6 months to 1 year of direct onsite monitoring experience is highly preferred. Proven ability to monitor investigator sites, assess investigational product compliance, and demonstrate outstanding critical thinking and problem-solving skills are essential. Proficiency in ICH-GCP and regulatory standards, along with excellent communication and organizational skills, is required. The ability to work collaboratively within a team is also necessary.
The Clinical Research Associate will monitor investigator sites, analyze root causes of issues, and implement solutions to improve compliance and minimize risks. Responsibilities include assessing investigational products, ensuring data accuracy through various review methods, and promptly reporting and resolving observed deficiencies. The role involves maintaining continuous contact with investigative sites, conducting monitoring tasks and visits according to the approved plan, and collaborating with project team members. The associate will provide trial status updates, update study systems, participate in investigator meetings, identify potential investigators, and commence/closeout clinical trial sites. Ensuring essential documents are complete, conducting on-site file reviews, contributing to project publications, facilitating communication between sites, the client, and the project team, and completing administrative tasks are also key duties. The role requires addressing company, client, and regulatory needs, audits, and inspections.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.