Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
Zymeworks is seeking a highly motivated professional who is looking to grow their career with our company. This position will report to the Clinical Program Manager and will be based in either Seattle, WA or Vancouver, BC.
The Clinical Trials Associate (CTA) position is responsible for supporting the clinical operations team in activities associated with the conduct of investigational clinical trials to ensure the successful completion of deliverables and goals.
Responsibilities include but are not limited to:
• Provides general administrative support to the clinical operations team and may act as a central contact for designated project communications, correspondence and associated documentation.
• Creates and maintains various clinical tools to track data including, but not limited to: study enrollment, study team contact lists, study team training, and laboratory sample tracking.
• Monitors Clinical Trial Master File. Collects and tracks incoming and outgoing clinical and regulatory documents. Ensures receipt, completeness and accuracy.
• Maintains databases for appropriate study administration including but not limited to SharePoint, Medidata RAVE, IXRS and lab portals.
• Tracks and manages Case Report Forms (CRFs), queries and clinical data flow. May assist with data cleaning.
• Maintains tracking system for clinical trial supplies and liaises with Supply Chain personnel to ensure the uninterrupted, timely supply of inventory to trial sites. Advises management of any issues or concerns.
• Assists with the creation of PowerPoint slides for activities such as Site Initiation Visit presentations, Investigator Meetings, and other study related team trainings. May prepare minutes of meetings.
• Creates and tracks purchase orders to pay vendors and reviews invoices for accuracy.
• Created purchase orders for vendor contracts.
• Carries out the function of the role in compliance with company Standard Operating Procedures (SOPs), working practices and regulatory guidelines.
• Fosters effective and collaborative working relationships with fellow employees and management.
Qualifications and Experience
• University degree preferably in the field of Biology, Life Sciences or related discipline and 1-year experience in academic or industry setting. Prior Clinical Trials Associate experience preferred.
• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team. Ability to establish and maintain effective working relationships.
• Good organizational skills and the ability to work effectively in a high paced, fast changing environment. Results-oriented.
• Basic knowledge of drug development and FDA/ICH regulatory requirements for clinical trials.
• Knowledge of FDA 21 CFR Part 11 for Handling of Electronic Records.
• Demonstrated ethics, integrity and professionalism.
• Ability to maintain and exhibit discretion at all times when handling confidential information.
• Good written and oral communication skills.
• Strong attention to detail and accuracy.
• Exposure to medical terminology.
• Proficiency with MS Office along with previous database experience.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.