the smart solution for Seattle jobs

Clinical Research Associate II

Company: Seattle Genetics, Inc.
Location: Bothell
Posted on: March 14, 2018

Job Description:

The successful candidate will be responsible for supporting study and site management. This position focuses on coordination of all activities required to evaluate, initiate, monitor and close clinical trial sites, as well as assisting with the preparation and review of study documents and plans, and review and analysis of clinical data for use in reports. Responsibilities: Assist with development / review of study documents, which may include clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals Assist with the review and analysis of clinical data for clinical trial report generation Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH Act as one of the primary contacts between Seattle Genetics, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Maintain close contact with clinical trial sites Instruct clinical investigators and their personnel in regard to clinical trial protocol regulatory requirements, and with clinical trial specific training May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of any clinical trial study May perform routine clinical trial site monitoring functions: Monitor compliance with study protocol, CFR, GCP/ICH and overall clinical objectives Verify adequacy of clinical data through comparison of case report forms to source documents Perform drug accountability and ensure adequate drug supply. Review and authorize research specimen sample shipments to central lab Collaborate with Drug Safety Group to ensure that study staff complies with the serious adverse event reporting requirements. Assist with management of clinical trial supplies On-going review of site regulatory file for completeness and accuracy. Ensure clinical trial site training records are current and maintained as required Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan May assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections May coordinate project meetings and assist in the support or maintenance of clinical trial timelines Assist in the maintenance of the Clinical Trial Master System and Trial Master file Ensure appropriate CRF completion and adequacy of clinical trial site monitoring Assist with management of research specimen samples. Assist with management of clinical trial site monitoring staff activities Assist with review and approval of clinical trial related invoices Maintain familiarity with new developments in clinical literature. Demonstrate increased ability to discuss scientific, medical and therapeutic area information. Perform all duties and responsibilities in accordance with CFR, GCP/ICH,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 Requires strong communication, interpersonal, and organizational skills Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive is preferred 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

Keywords: Seattle Genetics, Inc., Seattle, Clinical Research Associate II, Healthcare, Bothell, Washington

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

Oncology Nurse Practitioner or Physician Assistant
Description: Only QUALIFIED Healthcare Professionals accepted Nurse Practitioner or Physician Assistant - Hematology Oncology Nurse Practitioner or Physician Assistant Seattle, WAResponsibilities of the Hematology (more...)
Company: National Coalition of Healthcare Recruiters
Location: Seattle
Posted on: 03/19/2018

Nurse Practitioner-Pediatrics in Washington
Description: Pediatrics opening in Seattle, Washington. This and other nurse practitioner jobs brought to you by VISTA has a great Pediatric
Company: Vista Staffing Solutions
Location: Seattle
Posted on: 03/19/2018

Permanent Family Practice Physician in Seattle, Washington
Description: Family Practice physician employment in Washington : Seattle, Washington - Seeking an experienced, board-certified physician leader to act as medical director focusing on quality of care and patient safety. (more...)
Company: Providence Health & Services
Location: Seattle
Posted on: 03/19/2018

Description: University of Washington 13 13 Location Seattle, Washington, United States 13 Salary Not specified 13 Job type Employee 13 Category Administrative / Office,Health Care,Nursing 13 Job status N/A (more...)
Company: University of Washington
Location: Seattle
Posted on: 03/19/2018

Nurse Practitioner: Remote (Tacoma
Description: Job Description Job Summary Care Connections, a division of Molina Healthcare, seeks Nurse Practitioners to join its growing team which will contribute to the company mission to bring quality health care (more...)
Company: Molina Healthcare
Location: Bothell
Posted on: 03/20/2018

Acute-Care - Medical Transcriptionist
Description: Acute-Care - Medical Transcriptionist Part-time Acute Care Tier 2 or Tier 3 Medical Transcriptionist working between 12 p.m. and 3 a.m. in your respective time zone Mommy Jobs Online is currently seeking (more...)
Company: Mommy Jobs Online
Location: Maple Valley
Posted on: 03/19/2018

Physician - Vascular Surgeon
Description: Job Number: 180066 br Department: General and Thoracic Surgery br Hours: 8-5, rotating call br Employer Medical Center in Seattle, Washington is recruiting a BE/BC Vascular Surgeon to join our (more...)
Company: Virginia Mason
Location: Seattle
Posted on: 03/19/2018

Nurse Practitioner or Physician Assistant - Cardiology
Description: Nurse Practitioner or Physician Assistant - Cardiology Job Number: 180507 Department: Cardiology Hours: 8:00am - 5:00pm Nurse Practitioner or Physician Assistant - Cardiology Virginia Mason Medical Center (more...)
Company: Virginia Mason Medical Center
Location: Seattle
Posted on: 03/19/2018

Denial Medical Coders
Description: Please only apply if you meet the qualifications and your resume must reflect your work experience. PT
Company: Mommy Jobs Online
Location: Kent
Posted on: 03/19/2018

1000 Weekly As a HealthCare REP. INTERVIEWING THIS WEEK
Description: We are a fast paced, highly motivated team working for a company that is ready to produce leaders. We have long history of taking in new hire and creating real
Company: Customer service Benefits Level 2
Location: Edmonds
Posted on: 03/19/2018

Log In or Create An Account


Forgot password?

Find us on Facebook

Find us on LinkedIn

Get the latest Washington jobs by following @recnetWA on Twitter!

Seattle RSS job feeds