Clinical Research Associate II
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.
- 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
- 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