Clinical Trials Associate
Clinical Trials 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 Seattle and will report to the Director, Clinical Operations.
- Provides general administrative support to the clinical operations team.
- Creates and maintains various clinical tools to track data including, but not limited to: study enrollment, study team contact lists, study team training, pharmacokinetic and laboratory data.
- Administers all study and related documents (correspondence, monitoring reports, contact reports, and other organizational documents) before and during the study. Prepares and sends study materials to investigator sites.
- Maintains paper and/or electronic Trial Master Files. Collects and tracks incoming and outgoing clinical and regulatory documents. Ensures receipt, completeness, and accuracy.
- Maintains databases for appropriate study administration, assessing cases and generating queries for critical or missing information. Interacts with Senior Manager, Data Management to post queries to clinical database, or directly with clinical study sites to obtain the missing case information.
- Tracks and manages Case Report Forms (CRFs), queries and clinical data flow. May act as central contact for the clinical team for designated project communication, correspondence and associated documentation.
- Maintains tracking system for clinical trial supplies and liaises with Supply Chain personnel to ensure the uninterrupted, timely supply of inventory to trial sites.
- Assists with the creation of PowerPoint slides for activities such as Site Initiation Visit presentations, Investigator Meetings, and other study related team trainings.
- Creates and tracks purchase orders to pay vendors and review invoices for accuracy.
- Carries out the function of the role in compliance with company Standard Operating Procedures (SOPs), working practices and regulatory guidelines.
Qualifications and Experience
- University degree preferably in the field of biology, chemistry or health sciences and 0 to 2 years’ previous professional 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.
- Basic knowledge of drug development and FDA GCP regulatory guidelines.
- Familiarity with FDA/ICH regulatory requirements for clinical trials is desired.
- Excellent oral and written communication skills, with particular attention to detail.
- Ability to appropriately handle confidential information.
- 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 http://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 forward your cover letter and resume to firstname.lastname@example.org.
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