Senior Clinical Research Associate

Seattle, United States

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary: Undisclosed

Position Type: Full Time

Job Description

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.

About the Position

Zymeworks is seeking a Senior Clinical Research Associate to assist with development and review of study documents, which may include clinical trial protocols, and performs all duties and responsibilities in accordance with CFR, GCP/ICH, SOPs, Training Guides and other applicable guidelines.

The position will be based in Seattle, WA and will report to the Associate Director, Clinical Operations.

Key Responsibilities

• 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.
• May 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 Education

• 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?

Innovation. Act with Integrity. Collaboration. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

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

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary($): Undisclosed

Position Type: Full Time

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