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Sr. Clinical Research Associate (Sr.CRA)

Employer
Zymeworks Inc
Location
Seattle, Washington State
Salary
Competitive salary and benefits
Closing date
Jun 30, 2019

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Job Details

Sr. Clinical Research Associate

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 be based in our Seattle office and will report to the Clinical Program Manager.

Key Responsibilities

The Sr. Clinical Research Associate (Sr.CRA) is responsible for all aspects of site management and monitoring activities oversight for assigned clinical studies. Sr. CRA will ensure studies are conducted according to Good Clinical Practices (ICH-CP) and applicable regulatory requirements.

Responsibilities include but are not limited to:

  • Responsible for all aspects of site management and monitoring activities oversight for assigned clinical studies
  • May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of any clinical study
  • Manage investigator site and site activities for patient safety and monitor site data to ensure quality data required for global regulatory submissions.
  • Contributes to the development/review of study documents, which may include clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals.
  • Conduct Site initiation visits and Sponsor oversight site visits
  • Review and ensure completion of site documents necessary for ethics and regulatory and Zymeworks requirement for site activation
  • Continuously assess site performance, processes, qualification of staff to ensure adherence to study protocol procedures for the duration of the clinical study
  • Track enrollment activities to ensure sites remain on track with site commitment for recruitment and patient retention
  • Maintains awareness of key study performance indicators for own sites and supports clinical trial managers in reviewing study metrics
  • Contributes to the development of training materials and study management tools.
  • Assists the clinical study team in coordinating investigator and study meetings, including preparation and presentation of information.
  • Identifies, recommends and implements process improvements and best practices.
  • Ensures studies are carried out according to the study protocol, SOPs, CFR, ICH/GCP guidelines and study-specific manuals and procedures; collaborates with clinical program manager to ensure inspection readiness.

Vendor Management

  • Performs all tasks required for oversight of monitoring activities including, but not limited to, reviewing monitoring visit reports in accordance with clinical monitoring plan, identifying trends and escalating as needed.
  • Ensure  electronic Trial Master File (eTMF) is audit ready at all times.
  • Manage third party vendors, including but not limited to Specialty labs, IXRS, imaging vendors
  • Reviews clinical trial related invoices.

Team Leadership

  • Participates in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function.
  • Develops and implements study specific processes and train study teams.
  • Contributes to the performance evaluation and oversight of CTA-CRA II activities
  • Fosters effective and collaborative working relationships with fellow employees, management and external partners

Qualifications and Experience

  • University degree in science/healthcare field or nursing and a minimum of 5 year’s experience in pharmaceutical/biotech, CRO or related experience or an equivalent combination of education and experience. CRA certification preferred.
  • Experience in Phase I-III clinical trials
  • CRO management is preferred
  • Oncology clinical research experience preferred
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team
  • Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment
  • Thorough knowledge of CFR and GCP/ICH requirements
  • Demonstrated ability to train others
  • Proficiency with MS Office products Word, Excel, PowerPoint, Share point) and other electronic systems (CTMS, EDC and eTMF)
  • Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 35%)

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.

How to Apply

If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.co.uk/jobs/view.php?id=147 .  Due to the high volume of applicants, only those selected for interviews will be contacted.

Company

Zymeworks Inc

Company info
Website

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