Zymeworks

Clinical Research Associate I

Clinical Development - Seattle, Washington

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. 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.

The Clinical Research Associate I will report to the Director, Clinical Operations and will be based in Vancouver, BC. or Seattle, WA.

Key Responsibilities:

• Assists in feasibility review and site selection process as appropriate.
• Assists with development/review of study training materials and study management tools.
• Assists with the review and cleaning of clinical study data.
• Assists the clinical study team in coordinating investigator and study meetings including preparation, production and distribution of materials.
• Provides appropriate training to Investigator site staff on protocol, study conduct, GCP guidelines and regulatory requirements.
• Monitors and tracks Investigator site performance utilizing various systems; escalates significant issues appropriately.
• Assists in the maintenance of the Clinical Trial Master File (TMF).
• Participates in Sponsor oversight monitoring visits.
• Assists with management of clinical supplies to sites and coordination with vendor(s).
• Assists with management of research specimen samples.
• Assists with review and approval of clinical trial related invoices.
• May perform User Acceptance Testing (UAT) for applicable systems such as EDC and IXRS.
• Performs all duties and responsibilities in accordance with ICH/GCP, SOPs, Working Instructions and other applicable guidelines.
• Fosters effective and collaborative working relationships with fellow employees, management and external partners.

Education and Experience:

BA/BS or equivalent or any relevant and qualifying training with a minimum of 2 years’ relevant clinical site management and/or pharmaceutical/biotech/CRO experience (oncology preferred) or an equivalent combination of education and experience.

Qualifications 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.
• Good knowledge and understanding of CFR, ICH/GCPH guidelines and regulatory requirements.
• Excellent oral and written communication skills.
• Travel up to 25% may be required.
• An equivalent combination of education and experience may be considered.
• Embody and champion Zymeworks’ values: Act with Integrity. Collaborate.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

Why Work for Us?

At Zymeworks, we stand for innovation, integrity, collaboration and care.

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 https://zymeworks.bamboohr.com/jobs/.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

How to Apply

If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.com/jobs/view.php?id=372. Due to the high volume of applicants, only those selected for interviews will be contacted.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 01/30/2021