Biospecimen Coordinator at Loxo Oncology
- Location: Stamford, CT or South San Francisco, CA or Remote
- Reports To: Biospecimen Manager
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.
The Biospecimen Coordinator will be responsible for tracking inventory and overseeing the downstream processing of oncology research and clinical biomarker samples. This individual collaborates with oncology clinical study teams and research teams including Clinical Trial Managers (CTMs), Data Managers, and a network of contract research labs.
Roles and Responsibilities of the Position*
- Utilize software tools to track inventory of oncology research and clinical biomarker samples
- Maintain accurate and concise inventory of research and clinical/preclinical oncology biomarker samples across drug programs and third-party labs
- Support clinical development teams to design biospecimen handling logistics with preferred vendors
- Maintain regular metrics of biospecimen activities for studies
- Track and resolve discrepancies with study team, sites, or CRO vendors within specified time frames
- Assist in developing biospecimen collection plans with vendors by aligning with the clinical study protocol for sample collection requirements.
- Use monitoring tools to proactively identify trends and provide feedback to internal departments
- Oversee shipments of biomarker samples from sample repositories to third party labs for testing
Required Qualifications and Background
- Bachelors’ degree in Life Sciences, health related field or equivalent experience
- Minimum of 3 years sample management experience in pharmaceuticals, laboratory, or biorepository setting
- Oncology experience required across all phases of clinical trials
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
- Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
- Excellent organizational skills with high attention to detail is required
- Strong computer skills (spreadsheets, word processing, etc.) is required
- Experience using sample management database is preferred
- Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
Physical Demands / Travel
- The physical demands of this job are consistent with light office duties.
- The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position’s work environment is in an office.
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