In-House Senior CRA (Remote)

Company: IowaLifeScience
Location: Bothell
Posted on: November 19, 2021

Job Description:

In-House Senior Clinical Research Associate Development - Bothell, Washington Description Summary The In-House Senior CRA is specifically an in-house role responsible for coordination of all clinical operations site management and monitoring activities required to initiate, monitor and complete clinical programs at the clinical trial site level. May act as mentor for less senior members of the Clinical Trial Team and provides clinical operation input to the clinical project team.

• Participate as a member on the assigned cross-functional study team and serve as the main point of contact for clinical site management and monitoring functions
• May act as Protocol Lead (PL) on one or more clinical trials
• Provide operational / clinical trial site management input to the key study documents including the protocol, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report as assigned
• Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan Develop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate
• Participate in the identification, evaluation and selection of clinical trial investigators/sites
• Manage clinical trial site monitoring team metrics (i.e., monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc.) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meets clinical trial and corporate goals
• Provide support to field CRAs and may assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. May conduct monitoring visits including pre study, initiation, interim monitoring and close visits as needed
• If any portion of the clinical monitoring function is conducted by a CRO, ensure performance meets expectations, as outlined in the CRO oversight plan and/or other applicable plans, and requirements of the trial
• Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate
• Overseas research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed
• Ensure completeness of clinical trial management system (CTMS) and Trial Master File (TMF) for assigned studies
• May assist in the preparation and follow-up of in-house and on-site Seagen sponsored quality audits, as well as regulatory authority inspections
• Problem-solve clinical trial and related personnel resource issues
• Train, mentor, and may manage Clinical Research Associates (dotted line), in clinical trial management processes and all applicable regulations
• Adhere to Clinical Operations or project specific quality documents (e.g., SOPs, work practices, training guides), as applicable
• Participate in development of department processes and best practices. Participate in the evaluation, training and refining of departmental Standard Operating Procedures (SOPs) and guidelines, and the development of standard reports, templates and forms Qualifications:
  • BA/BS or equivalent or any relevant and qualifying training, RN or health care professional, with at least 6 years of pharmaceutical clinical development experience or equivalent. Advanced degree preferred
  • Oncology/hematology clinical trial experience, NDA/BLA filing experience, international clinical development experience is preferred
  • Experience in Phase I-III trials and CRO management is preferred
  • Proficiency in CFR and GCP/ICH requirements, as well as experience working with European Clinical Trial Directive is preferred
  • Must be willing to travel up to 20%
  • Excellent leadership, communication, and organizational skills
  • Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously
  • Frequently interacts with subordinates, supervisors, customers or functional peer group managers and will interact with senior management
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF) Education:
    • BA/BS or equivalent or any relevant and qualifying training, RN or health care professional, with at least 6 years of pharmaceutical clinical development experience or equivalent. Advanced degree preferred As a leading employer in our industry, Seagen 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. To learn more about Seagen, please visit www.seagen.com. Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment. To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Keywords: IowaLifeScience, Seattle , In-House Senior CRA (Remote), Other , Bothell, Washington