Seattle Genetics

Field CRA I

Description

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.

Summary

The Field CRA 1 is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor, and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines.

Responsibilities:

• Act as liaison between the in-house team, vendors, and multiple clinical sites.
• Develop strong site relationships, maintaining close contact with sites by phone, written correspondence, and remote and on-site visits.
• Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, and other study materials as applicable.
• Under appropriate supervision, help identify and qualify potential investigators. Perform Pre-Study Site Visits.
• Assist with start-up activities, including essential document review and collection as requested.
• Under appropriate supervision, perform Site Initiation Visits.
• Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements.
• Perform Interim Monitoring Visits for assigned studies:
• Monitor site compliance with study protocol and GCP.
• Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
• Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.
• Perform drug accountability and ensure adequate drug supply.
• Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required.
• Assist study team as necessary in resolving lab queries and other issues.
• Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.
• Ensure adequacy of clinical supplies to the site.
• Collect and review site essential documents and ensure site regulatory files are complete and accurate.
• Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals.
• Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.
• Ensure site staff is appropriately trained and site responsibilities are delegated to qualified staff.
• Perform Close Out visits as assigned.
• Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
• Track, report and follow all action items to resolution.
• Maintain CTMS in a timely fashion, utilizing available reports and study tools.
• Work proactively with sites to address site issues and action items to obtain swift resolution and/or escalate to PL/PI per CMP.
• Assist Data Management as required.
• Provide co-monitoring support as requested or as necessary to develop additional skills.
• May assist in the preparation and follow-up of on-site Seattle Genetics sponsored quality audits as assigned.
• Complete routine administrative tasks in a timely manner.
• Demonstrate increased ability to discuss scientific, medical and therapeutic area information.
• Attend staff meetings and trainings as required.
• May have opportunities to contribute to other clinical trial related activities.
• Perform all duties and responsibilities in accordance with the Code of Federal Regulation, GCP/ICH Guidelines, Seattle Genetics’, INC. policies, department and project specific requirements (e.g. SOPs, work practices, training guides). Expected to expand CFR, GCP/ICH knowledge.

Qualifications:

• BA/BS, or equivalent, or a minimum of 3 years of other relevant experience and training. Prior oncology or monitoring experience is preferred.
• Knowledge of CFR and GCP/ICH is required.
• Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred).
• Previous experience with EDC and CTMS systems preferred.
• Requires effective organizational and time management skills.
• Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative.
• Strong communication and interpersonal skills.
Emerging ability to discuss scientific, medical and therapeutic area information with medical professionals
• Flexibility towards work assignments, learning, and travel.
• Able and willing to travel approximately 60-80%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.
• Responsive and proactive, a team player.

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

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Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 02/08/2019