Senior Clinical Research Associate
Senior Clinical Research Associate
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
About the Position
Zymeworks is seeking a highly-motivated Senior Clinical Research Associate to help launch new programs and support clinical trials that have a meaningful impact on the lives of patients. This is a unique opportunity to become an integral part a growing Clinical Operations team within a company that has well-established Research and Development roots in Vancouver. The right candidate will have the ability to utilize their knowledge, drive, and talent to influence the success of the team and product candidates.
This position will be based in Seattle, WA and will report to the Clinical Program Manager.
• Assists with development/review of study documents, which may include clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and lab manuals.
• Conducts data review to ensure a clean and complete clinical database
• Evaluates adequacy of potential clinical investigators and clinical trial sites, including evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH.
• Acts as one of the primary contacts between Zymeworks, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Maintains close contact with clinical trial sites.
• Instructs clinical investigators and their personnel in regard to clinical trial protocol regulatory requirements, and with clinical trial specific training.
• May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of trial.
• Presents trial information at Site Initiation Visits or Investigators meetings.
• Assist in the preparation and follow-up of in-house and on-site Zymeworks sponsored quality audits, as well as, regulatory authority inspections.
• May coordinate project meetings and assist in the support or maintenance of clinical trial timelines.
• Assists in the maintenance of the Clinical Trial Master System and Trial Master file.
• Ensures appropriate CRF completion and adequacy of clinical trial site monitoring.
• Assists with management of research specimen samples.
• Assists with management of clinical trial site monitoring staff activities.
• Assists with review and approval of clinical trial related invoices.
• Maintains familiarity with new developments in clinical literature. Demonstrates increased ability to discuss scientific, medical and therapeutic area information.
• Performs all duties and responsibilities in accordance with CFR, GCP/ICH, SOPs, Training Guides and other applicable guidelines.
• Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
• BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years clinical site management and/or monitoring experience (oncology strongly preferred) or an equivalent combination of education and experience.
• 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
• Thorough knowledge and understanding of CFR and GCP/ICH guidelines and regulatory requirements
• Excellent oral and written communication skills
• Experience with electronic systems (e.g. eCRFs, CTMS, eTMF, IXRS lab portals, etc.)
• Ability to travel up to 25%
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.