Clinical Trials Associate (12-month contract)
About The Position
The Clinical Trials Associate provides administrative and operational support to clinical trial teams. The role supports preparation, maintenance, quality control, and filing of essential trial documents; helps keep study conduct and oversight trackers current; and maintains study conduct metrics such as start-up timelines, enrollment, screen-failure, and deviation rates. The Associate also supports vendor oversight, patient data review, and invoice review in collaboration with internal teams and external vendors. The role requires work in accordance with company SOPs, working practices, and regulatory guidelines. It involves collaborative coordination with global cross-functional teams and management to meet trial milestones and ensure timely, accurate communication. The Associate serves as a back-up to the Clinical Trial Manager when needed. This is a 12-month contract. Zymeworks describes its total rewards package as including competitive salaries, benefits, a strong work environment, and opportunities for professional growth. The role is not eligible for relocation or immigration support.
Requirements
- Bachelor’s degree, preferably in biology, chemistry, or health sciences.
- 1–3 years of previous clinical research experience.
- Proven interpersonal skills and ability to collaborate as a member of cross-functional and global teams and maintain effective working relationships.
- Good organizational skills and ability to work effectively in a fast-paced, rapidly changing, compliance-driven environment.
- Results-oriented and flexible attitude.
- Ability to track and manage key dates and deadlines.
- Basic knowledge of drug development and FDA GCP regulatory guidelines.
- Excellent oral and written communication skills, with attention to detail.
- Ability to appropriately handle confidential information.
- Proficiency with MS Office and Excel.
Nice To Haves
- Prior Clinical Trials Associate experience in oncology.
- Familiarity with FDA/ICH regulatory requirements for clinical trials.
Responsibilities
- Provide administrative support to clinical trial teams.
- Assist with preparation and maintenance of essential trial documents.
- Organize internal study team meetings and issue agendas and minutes with approval from the CTM.
- Assist and support the eTMF Manager with eTMF quality control.
- Set up and ensure study-related documents are filed according to the folder structure in the internal SharePoint repository.
- Assist the CTM in maintaining internal study conduct and other oversight trackers.
- Maintain study conduct metrics, including study start-up timelines, enrollment rates, screen-failure rates, and deviation rates.
- Provide monitoring review oversight of an external vendor.
- Review patient data in collaboration with cross-functional teams and the external vendor.
- Assist in reviewing invoices, including pass-through costs, by referring to site agreements and patient enrollment and/or monitoring visit trackers.
- Perform the role in compliance with company SOPs, working practices, and regulatory guidelines.
- Foster collaborative working relationships with global cross-functional teams and management to help ensure trial milestones are met.
- Promote timely and accurate communication among internal and external teams.
- Serve as back-up to the CTM when needed.
Benefits
- Competitive salaries.
- Generous benefits.
- Outstanding work environment.
- Opportunities for professional growth.
- Industry-leading vacation and paid time off.
- Medical, dental, and vision benefits by country.
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What This Job Offers
Career Level
Entry Level
