Zymeworks

Clinical Research Associate II

Clinical Operations - Seattle, Washington United States

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. 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.

Company Description

Zymeworks is seeking a highly-motivated Clinical Research Associate (CRA) looking to grow their career with our company. The CRA II position is responsible for supporting the clinical operations team in activities associated with the conduct of investigational clinical trials to ensure the successful completion of deliverables and goals. The position will report to a Clinical Trial Manager (CTM) or Sr CTM, Clinical Operations and can be based in Seattle, WA, Vancouver, CA or be remote.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

• Supports the clinical operations team on one or more studies under the guidance of the CTM.
• Evaluates and tracks CRO’s monitoring activities and performance and escalates significant issues appropriately.
• Assists in evaluating adequacy of potential clinical investigators and clinical trial sites, including evaluation of facilities, personnel, patient enrolment potential, and adherence to ICH/GCP.
• Contributes to the development, review, and revision of study documents, which may include (but are not limited to) clinical trial protocols, Informed Consent Forms, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan, and lab manuals.
• Prepares trial information for Site Initiation Visits, Investigator meetings or other study-related team trainings.
• Manages assigned study vendor related tasks including but not limited to reconciliation and tracking of research specimen samples.
• 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 as needed.
• Collaborates closely with Data Management (DM) team members for DM related activities. Conducts data review to ensure a clean and complete clinical database. Monitors the progress of data entry and query resolution at sites.
• Creates and maintain various clinical tools to track data and maintain the flow of information.
• Ensures the review and approval of clinical trial related invoices and escalates out of scope work.
• May participate in the review of site budgets/contracts.
• Responds to or triages site communications to uphold adherence to protocol and regulatory requirements.
• Monitors and tracks Investigator site performance utilizing various systems; escalating significant issues appropriately.
• Helps to track and manage subject recruitment status at all study sites. May manage cohort assignments if applicable to the study.
• Performs Quality Control and maintenance of the Clinical Trial Master File (TMF) in conjunction with the TMF Management Team to ensure essential documents are filed accurately, timely and completely.
• Assists in the preparation and follow-up of Zymeworks sponsored quality audits, as well as regulatory authority inspections.
• Conducts sponsor oversight monitoring visits and reviews monitoring reports and monitoring visit letters to assess trends and site performance.
• Participates in User Acceptance Testing (UAT) for applicable systems such as EDC and IXRS.
• Performs all duties and responsibilities in accordance with CFR, ICH/GCP, SOPs, Working Instructions, and other applicable guidelines.
• Participates in department or company working groups and meetings and may mentor more junior CTAs or lead CTA or CRA initiatives.
• Fosters effective and collaborative working relationships with fellow employees, management, Investigator and site staff, and other external partners.

Qualifications and Education

• BA/BS or an equivalent combination of education and qualifying experience.
• A minimum of 3 years of clinical operations experience in the pharmaceutical industry or a related sector. Prior experience as a Clinical Research Associate is a plus.
• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team.
• Flexibility to perform a broad range of trial-based responsibilities.
• Excellent communication, organizational, and analytical skills, and the ability to work effectively in a high paced, fast changing environment.
• Working knowledge of drug development, CFR, ICH/GCP guidelines and applicable regulatory requirements.
• Strong attention to detail and accuracy.
• Proficiency with MS Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (e.g., Veeva eTMF) and databases (e.g., Medidata RAVE EDC). Experience with Zoom, Smartsheet and Spotfire is helpful.
• Ability to travel on occasion for oversight visits, meetings, or trainings (minimal travel).
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

How to Apply

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: 05/07/2022