Clinical Research Associate II (In-House)

Location
Bothell, WA, United States
Posted
Jul 23, 2018
Ref
1-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 2 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:
  • Assist, or may lead CTM effort to develop, review and track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals
  • Ensure 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
  • Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH
  • Train clinical investigators and their personnel in regard to clinical trial protocol and regulatory requirement
  • Collect and review site essential documents, including site ICF changes
  • Act as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites
  • Travel alone or with CRO representative to clinical trial sites to monitor compliance with the clinical trial protocol, CFR, GCP/ICH guidelines, and overall protocol objectives
  • Assist with management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or radiology scans
  • Assist with management of clinical trial safety and efficacy issues, including, but not limited to: review and follow-up of Serious Adverse Event reports
  • Perform data listings review and generate 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
  • Conduct clinical team meetings, including agenda preparation, minutes, and action item tracking as assigned
  • Ensure appropriate CRF completion and review and approval of clinical trial site monitoring reports
  • Assist with the review and analysis of clinical data for clinical trial report generation
  • Assist with review, approval and reconciliation of clinical trial related invoices
  • Train and mentor junior-level team members
  • Actively contribute to process improvement
  • Demonstrate increased ability to discuss scientific, medical and therapeutic area information
  • If assigned Site CRA role, 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 2 for more detailed descriptions of job duties and responsibilities
  • 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, color, religion, sex, national origin, protected veteran status, or disability status.

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.