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Clinical Research Associate - Central Region
Bothell, WA 98012 United States
This position is responsible for monitoring and management of clinical sites for trials conducted by the Clinical Development Department. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with CFR, ICH/GCP guidelines and Seattle Genetics’ or designee’s SOPs.
• Act as the liaison between Seattle Genetics, the CRO, vendors, and multiple clinical sites. Maintain close contact with sites by telephone, correspondence, and on-site visits.
• Apply the applicable SOPs, Clinical Monitoring Plan, Research Specimen Manual and CRF Completion Guidelines as indicated.
• Identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with and track start up activities including essential document review and collection, and facilitating Ethics Committee, other committee, and budget/contract review and approval process.
• Perform Site Initiation Visits. Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures and CFR, and GCP/ICH Guidelines.
• Perform Interim Monitoring Visits.
o Monitor compliance with study protocol, CFR, GCP/ICH and overall clinical objectives.
o Verify adequacy of clinical data through comparison of case report forms to source documents.
o Perform drug accountability and ensure adequate drug supply.
o Review and authorize research specimen sample shipments to central lab.
o Collaborate with Drug Safety Group to ensure that study staff complies with the serious adverse event reporting requirements.
o Coordinate supply of clinical supplies to the site.
o Ensure site regulatory file is complete and accurate.
o Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance.
o 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 on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
• Assist Data Management as required.
• Complete routine administrative tasks in a timely manner.
• Attend staff meetings and training sessions as required.
Education, training, experience:
• BA/BS or equivalent in a scientific discipline or any relevant and qualifying medical training with a minimum of 3 years of relevant clinical trial management experience.
• Excellent organizational, interpersonal, verbal, and written communication skills, (including experience in making presentations)
• Demonstrate ability to discuss scientific, medical and therapeutic area information.
• Strong working knowledge of CFR, and ICH/GCP requirements.
• Flexibility towards work assignments, new learning and travel. Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail.
• IT literate with a strong working knowledge of PC functions and recent experience with Microsoft based applications, Electronic Data Capture Systems, and CTMS Monitoring Module, Impact or like system. Experience in oncology, and monitoring complicated trials.
• Must live within the territory, Texas (preferred).
Seattle Genetics is an equal opportunity employer.
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