Senior Clinical Trials Specialist

Position Overview

The Senior Clinical Trial Specialist will be responsible for supporting and contributing to the Adaptive Biotechnologies Dx Customer Operations team to ensure our customers and their patients have an exceptional experience.  This position will directly support clinical trials for the company’s commercially available diagnostic product, clonoSEQ™, which is an assay for the detection and monitoring of minimal residual disease (MRD). 

Key Responsibilities and Essential Functions

• 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

Position Requirements

• Bachelor’s degree or an equivalent combination of education and experience
• 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
• 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

Working Conditions

• Some travel may be required

#LI-Remote

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Compensation

Salary Range: $80,200 - 120,400

Possible “other compensation” elements to include:

• equity grant
• bonus eligible