[Remote] Senior Clinical Trials Specialist

Note: The job is a remote job and is open to candidates in USA. Adaptive Biotechnologies is hiring a Senior Clinical Trials Specialist to support its Dx Customer Operations team and provide an exceptional experience for customers and patients. The role supports clinical trials for clonoSEQ, the company’s diagnostic assay for detecting and monitoring minimal residual disease, and coordinates trial requirements, samples, stakeholders, and customer support.

Responsibilities

• Maintain the Clinical Trial Managers in maintaining detailed requirements of MRD-related trial protocols, facilitating sample processing and data generation
• Support Adaptive Biotechnologies’ Medical Science Liaison (MSL) team as needed in the design and management of Adaptive’s clinical trial collaborations
• Partner with Quality Assurance to document deviations and nonconformances in accordance with GCLP practices
• Coordinate and communicate with internal and external stakeholders regarding dual workflow patient samples
• Lead cross-functional efforts to create customer-specific collateral for clinical trials
• Assist customers with patient linking requests which may involve re-accessioning or re-processing events
• Tier II support for customer issue and complaint resolution
• Lead onboarding activities for new clinical trial customers
• Serve as point of contact for trial investigators and/or their staff to answer or triage trial-related questions regarding ordering, specimen type and sample processing, and reporting timeframes
• Attend clinical trial investigator / participating site meetings and generate meeting / project documentation as needed
• Partner with BSM and Lab Operations teams to ensure smooth sample receipt, processing and results delivery in accordance with contractual trial agreements and analytical plan
• Act as the Subject Matter Expert (SME) on assigned clinical trial requirements
• Work closely with many of the company’s internal departments, including Biological Sample Management, Lab Operations, and Accounts Receivable, Medical Affairs, and Quality Assurance
• Work with the larger Dx Customer Operations team to streamline processes, ensure efficiency and improve existing standard operating procedures
• Contribute to a culture of success and ongoing business goal achievement
• All other duties as assigned

Skills

• Bachelor's degree or an equivalent combination of education and experience
• Strong customer and patient focus with a demonstrated understanding of HIPAA requirements
• Familiarity with basic laboratory and customer service-related systems such as LIMS and SFDC
• Strong attention to detail and meticulous data entry skills
• Ability to manage multiple tasks to completion in a dynamic office setting
• Effective and professional communication skills for engagement with both internal and external personnel
• Excellent written communication skills are required, including technical proficiency with Word, Excel, PowerPoint, etc
• Flexible team-player with the ability to take on new assignments
• Adaptive is not currently sponsoring candidates requiring work authorization support for this position
• 2 to 4 years of prior Clinical Trials, Clinical Services or Client Services experience is highly preferred
• Experience working with GCLP trials or in an FDA regulated environment preferred

Benefits

• Possible equity grant
• Bonus eligible

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