Clinical Research Associate I

Location
Bothell, Washington
Posted
May 08, 2018
Ref
2FoXOr7fw3
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

The In-House CRA is specifically an in-house role responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities.

A CRA 1 may also have the role of Site CRA which is primarily responsible for 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:

  • Assist with review and tracking of study documents including ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals
  • Ensure the the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state.  Review for compliance and address findings as needed
  • Track site and study status as assigned
  • Train clinical investigators and their personnel in regard to clinical trial protocol and regulatory requirements
  • Collect and review site essential documents, including review of site ICF changes
  • May act as a primary contact with field CRAs, clinical trial sites and vendors
  • Assist with management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or radiology scans
  • Under appropriate supervision assist with review of data listings and generation of data queries.
  • Assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
  • Assist with the conduct of clinical team meetings, including agenda preparation, minutes, and action item tracking
  • Assist with review and reconciliation of clinical trial related invoices
  • Train and mentor junior-level team members
  • Actively contribute to process improvement
  • Starting to become proficient in discussing scientific, medical and therapeutic area information as related to assigned studies
  • Under appropriate supervision, may conduct clinical trial site co-monitoring and independent monitoring visits including:  Pre-study, Initiation, Interim Monitoring, and Close-out visits.  Follow all outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites.  See job description for field CRA 1 for more detailed descriptions of job duties and responsibilities
  • 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 3 years of relevant clinical trial management experience
  • Knowledge of CFR and GCP/ICH is required
  • 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
  • Travel up to approx. 20% may be required

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.