- Manages tracking, logistics and quality operations for unique biological specimens (e.g., biopsy slides, digital images) supporting clinical trials from collection to final disposition through effective tactical interactions with clinical teams, Bioanalytical group, sites, and central and specialty lab partners.
- Maintains on-going communications and expertly manages the delivery of samples to support internal clinical trial teams and external vendors to ensure transparency of the condition of clinical sample collection and movement throughout the course of the trials.
- Drives recovery of samples from clinical sites and reconciliation of sample to clinical database.
- Reviews status of specimens received and ensures completeness of associated data prior to analysis.
- Acts as the direct specimen management liaison with clinical trial team members (e.g. protocol managers, clinical scientists, pharmacokinetic and biomarker leads and bioanalytical services); understanding the sample/data related critical time points and ensuring all escalation is executed in a consistent and timely fashion to avoid unnecessary churn.
- Ensures all issues are logged, risks are escalated, and items are driven to closure in support of team goals and timelines.
- Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress of internal and external teams thus moving issues to resolution.
- Actively maintains a Book of Work for his/her respective studies; ensuring protocol status and resource demand are updated for management assessment on a monthly basis.
- Fosters teamwork between client functional areas; creating a team environment based on mutual trust and respect. Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis.
- Participates in and/or lead sample management process improvement projects.
- Expert use of Excel (or other software) for tracking, reporting sample status.
- Significant experience with detailed tracking, demonstrates a high level of attention to detail.
- 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.
- Other duties as assigned.
- Bachelor's degree in biomedical, life science or related field of study.
- Minimum of 3 years pharmaceutical, biotechnology or CRO clinical research experience.
- Minimum of 2 years of experience in clinical drug development/clinical trial execution. Exposure to biomarkers, pharmacokinetics or immunogenicity sample activities required, including sample collection procedures and logistics considerations. Basic understanding of data management required.
- Knowledge of applicable regulatory authority, compendia and ICH guidelines
- Firsthand knowledge of laboratory operations highly desired.
- Ability to understand and independently apply GCPs and /or GLPs to everyday work with regard to documentation and the use of lab systems at vendors (e.g., LIMS)
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Clinical Sample Logistics Specialist - Sacramento, United States - Coda Staffing
Description
Job Description
Job DescriptionPOSITION SUMMARY: This is a temp to perm position. Must be okay starting off contract.
The Clinical Sample Logistics Specialist conducts logistics processes, in collaboration with other clinical operations personnel, ensuring that projects are progressing and systems are set up and maintained according to quality standards, Standard Operating Procedures and applicable ICH-GxP* and other applicable local regulation and industry guidelines.
GxP refers to the relevant ICH guidelines which include (but not limited to) Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP).
CORE ACCOUNTABILITIES:
The successful candidate must be able to perform each of the following satisfactorily, with or without an accommodation:
QUALIFICATIONS:
REQUIRED KNOWLEDGE AND ABILITIES:
Strong verbal and written communication skills are essential.
Excellent organization and multi-tasking skills.
Exceptional interpersonal skills and problem-solving capabilities.
Proven meeting planning skills.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to think strategically in order to improve current processes.
