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Senior Clinical Trials Specialist
Adaptive Biotechnologies Corp.. Maintain detailed requirements of MRD-related trial protocols, facilitating sample processing and data generation .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial protocols and collaborating with cross-functional teams to ensure compliance with GCLP practices. Proficient in customer service and communication, with a strong focus on patient needs and data accuracy.
Highest-signal resume keywords
Clinical Trials ExperienceGCLP ComplianceCustomer Service SkillsData Entry AccuracyEffective Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementData GenerationSample ProcessingDocumentation of DeviationsPatient LinkingComplaint ResolutionMeeting DocumentationAnalytical PlanningTechnical Proficiency in WordTechnical Proficiency in Excel
Soft Skills
Attention to DetailTeam CollaborationAdaptabilityCustomer FocusProfessional Communication
Tools & Technologies
LIMSSFDC
Industry Keywords
FDA Regulated EnvironmentHIPAA ComplianceQuality AssuranceBiological Sample ManagementClinical Services
Tech Stack
Tools & technologiesSFDC
About the role
Key responsibilities & impact- Maintain detailed requirements of MRD-related trial protocols, facilitating sample processing and data generation
- Support the Medical Science Liaison team in designing and managing clinical trial collaborations
- Partner with Quality Assurance to document deviations and nonconformances in accordance with GCLP practices
- Coordinate with internal and external stakeholders regarding dual workflow patient samples
- Lead creation of customer-specific clinical trial collateral
- Assist customers with patient linking requests, including re-accessioning or re-processing events
- Provide Tier II support for customer issues and complaint resolution
- Lead onboarding activities for new clinical trial customers
- Serve as point of contact for trial investigators and staff regarding ordering, specimen type, sample processing, and reporting timeframes
- Attend investigator and participating-site meetings and generate meeting/project documentation
- Partner with Biological Sample Management and Lab Operations to ensure sample receipt, processing, and results delivery according to trial agreements and analytical plans
- Act as subject matter expert on assigned clinical trial requirements
- Collaborate with Biological Sample Management, Lab Operations, Accounts Receivable, Medical Affairs, and Quality Assurance
- Streamline processes, improve efficiency, and enhance standard operating procedures
- Contribute to business goal achievement
- Perform other duties as assigned
Requirements
What you’ll need- 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 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, 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
Benefits
Comp & perks- Equity grant
- Bonus eligible
- Some travel may be required
- Adaptive benefits program (benefits-at-a-glance referenced)