- The Clinical Sample Logistics – Temp conducts logistics processes, in collaboration with other clinical operations and cross functional personnel, ensuring that disposition of specimens are tracked, and that related 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), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Maintains and manages tracking, logistics and quality operations for biological specimens supporting clinical trials from collection to analysis through effective tactical interactions with clinical teams, clinical sample logistics, sites (if necessary), and central and specialty lab partners. Similarly, may oversee the management of other clinical data parameters (e.g., MRI scans, ultrasounds, ECG tracings, etc.)
- Implements and imposes GCP principals in all aspects of collection, storage, shipping, etc. of biological specimens. Similarly, imposes other GxP principles to these activities.
- Maintains on-going communications and reporting functions with internal clinical trial teams to ensure transparency of the condition of clinical sample collection and movement throughout the course of the trials.
- Acts as the direct specimen management liaison with clinical trial team members (e.g. protocol managers, clinical scientists, pharmacokinetic and biomarker leads and bio-analytical 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.
- Coordinates, oversee and manage shipment of specimens, generally, across storage and/or analytical facilities.
- Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress of internal and external teams thus moving issues to resolution.
- Will interact directly with Clinical (e.g., CRAs, managers), site staff, vendors in U.S. and Europe (other worldwide, as necessary) to provide support in project-specific tasks and the overall management of clinical trials.
- Maintains laboratory testing monthly study metrics and trending to identify any issues that require escalation to senior management.
- Will prepare correspondence, spreadsheets and presentations for projects/studies.
- Will regularly access study/vendor websites to run reports and ensure distribution of information.
- Route, track and file Clinical documents.
- Participates in and/or lead sample management process improvement projects.
- 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.
- RN or Bachelor’s degree in biomedical, life science or related field of study preferred.
- Minimum of 1 year pharmaceutical, biotechnology, CRO or Clinical Site supporting clinical research experience required.
- Minimum of 1 year 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. Good understanding of data management required.
- Knowledge of GLP, GCLP and applicable regulatory authority, compendia and ICH guidelines
- Firsthand knowledge of laboratory operations highly desired.
- Ability to understand and independently apply GxPs to everyday work with regard to documentation.
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.
- Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar databases required.
- 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.