Clinical Research Associate II (In-House)

Location
Bothell, WA, United States
Posted
Oct 26, 2018
Ref
oSRY7fwy
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

This in-house position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities.

A CRA II may also be responsible for a management of some Seattle Genetics clinical trial sites. This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.

Responsibilities:

The CRA II will assist with, or may lead study related activities, including but not limited to:
    • Assessing adequacy of potential clinical investigators and clinical trial sites, collect and review site essential documents, including site ICF changes, and train clinical investigators and their personnel in regard to clinical trial protocol and regulatory requirements
    • Development, review and tracking of study documents, including: ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals
    • Ensuring appropriate CRF completion and review and approval of clinical trial site monitoring reports
    • Review and analysis of clinical data for clinical trial report generation; review, approval and reconciliation of clinical trial related invoices; review of data listings and generation of data queries
    • Ensuring the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state, including reviewing for compliance and addressing findings as needed
    • Management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or radiology scans
    • Preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
    • Tracking site and study status as assigned
    • Acting as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites
    • Conducting clinical team meetings, including agenda preparation, minutes, and action item tracking
    • Other trial related duties as assigned, based on level of experience
    • Additional Responsibilities include:
    • Train and mentor junior-level team members
    • Actively contribute to process improvement
    • Demonstrate increased ability to discuss scientific, medical and therapeutic area information
    • May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of any clinical trial study
    • Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, Training Guides and other applicable guidelines

Qualifications:
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevant clinical trial management experience
  • Knowledge of CFR and GCP/ICH requirements is required
  • Experience on Global Clinical Trials is preferred
  • Proficiency Microsoft Office Products-Word, Excel, PowerPoint, SharePoint (preferred)
  • Requires effective organizational and time management skills
  • Able to multi-task under limited direction and on own initiative
  • Strong communication and inter-personal skills
  • Highly responsive and proactive, a team player

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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.