Clinical Biosample Associate II

Location
San Francisco, CA, United States
Posted
Oct 06, 2018
Ref
3342-530-2018
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Position Overview

Responsible for tracking and management of protocol-level samples and scans.

Escalates to Clinical Trial Leader, Clinical Pharmacology, Bioanalytical and Clinical Development as appropriate where there are areas of departure from established standards or recommended guidelines. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Performs biomarker and pharmacokinetic/immunogenicity sample tracking using advanced Microsoft Excel skills: generating reports and trackers, collaborating with internal and external partners for clarification and escalation of issues to the clinical team. Performs tracking of images using advanced Microsoft Excel skills, generating reports and trackers, collaborating with internal and external partners for clarification and escalation of issues to the clinical team. Maintains sample and image collection instructions for sites to ensure clarity, quality and compliance. Responsible for tracking and management of document versions aligned with protocols and amendments. Reviews laboratory and imaging manuals, associated forms and labels. Provides training support for investigators/site teams for proper collection techniques, time point requirements and sample/image handling to ensure viability and data reliability. Supports escalation of sample and imaging management concerns during the execution of the study. Ensures all issues are documented, advises on mitigation and remediation, escalates issues and drives to closure in support of team goals and timelines. Actively maintains status updates for routine reporting to study team. Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress, moving issues to resolution. Displays strong written and oral communication skills. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large and small teams to achieve business goals with professionalism and poise.

Minimum of 1 year of experience in clinical drug development and clinical trial execution. College degree (Bachelors) or equivalent relevant experience required. Biological sample management including biomarkers, pharmacokinetics and/or immunogenicity in clinical trials preferred. Immunology/Immuno-Oncology experience preferred. Exposure to central imaging and/or ECG management in clinical trials preferred. Understanding of regulatory guidance for biological sample and imaging requirements, including considerations for patient privacy, protocol development and ICF preferred. Firsthand knowledge of laboratory or imaging/ECG operations highly desired. Basic understanding of data management. Demonstrable knowledge of sample tracking, issue escalation and resolution processes. Demonstrated ability to analyze and interpret problems and data from a variety of sources. Experience and fluency with MS Office tools (Word, Excel, PowerPoint, Project). Must be able to demonstrate proficiency in the creation and efficient navigation of Excel trackers.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.