Senior Field Clinical Research Associate
2 mesi fa
Description Position at Seagen Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found atPosition Summary:
The Sr. Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. The Sr. Field CRA may act as mentor for junior members of the Field CRA team. This role also provides operational input to clinical study teams and contributes to department initiatives.Principal Responsibilities:
Monitor site compliance with study protocol, and GCP. Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines. oPerform drug accountability and ensure adequate drug supply. Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required.Assist study team as necessary in resolving lab queries and other issues.Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.Ensure adequacy of clinical supplies to the site.Collect and review site essential documents and ensure site regulatory file is complete and accurate.Monitor site compliance with IRB policies/processes and ensure timely submissions and approvals.Track and report progress of study, datamonitoring, protocol variations, issue resolution, and follow up compliance.Ensure site staff is appropriately trained, and site responsibilities are delegated to qualified staff. Perform Close Out visits as assigned. Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.Track, report, and follow all action items to resolution.Maintain CTMS in a timely fashion, utilizing available reports and study tools.Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.Assist data management as required.Provide co-monitoring support as requested.Contribute to the preparation and follow-up of on-site Seattle Genetics sponsored quality audits and regulatory authority inspections as assigned.Complete routine administrative tasks in a timely manner.Discuss scientific, medical and therapeutic area information. Attend staff meetings and trainings as required. May have opportunities to contribute to other clinical trial related activities, including vendor management, data review, or other study-related activities. Contribute to department initiatives.May mentor junior-level team members.May contribute to development and revision of study specific Clinical Monitoring Plans and CRF Completion Guidelines and other study documents.May serve as a Subject Matter Expert (SME).Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides).Qualifications:
BA/BS, or equivalent, or relevant experience and training with at least 6 years of pharmaceutical/biotech experience. RN or health care professional preferred.Prior monitoring experience is required. Oncology/hematology clinical trial experience is preferred. FDA/EMA inspection experience is preferred.Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).Excellent communication and organizational skills. Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals. Ability to proactively handle multiple tasks, manage a diverse range of functional activities, prioritize workload and solve problems simultaneously.Flexibility towards work assignments, learning, and travel. Able and willing to travel approximately 55-75%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.Highly responsive and proactive, a team player.Education:
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