Clinical Sample Coordinator
Pionyr Immunotherapeutics, Inc., a growing well-funded clinical stage immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced Clinical Sample Coordinator. This pivotal role, based at our South San Francisco location, will report to our head of translational research and be responsible for planning, coordinating, and managing the lifecycle of patient samples. This role will be the primary liaison with Pionyr’s Research and Clinical Operations groups, as well as our external vendors.
Specific Responsibilities include (but not limited to):
- Serves as liaison and subject matter expert (SME) related to Pionyr’s biosample logistics.
- Coordinates with translational medicine and clinical operations to ensure that clinical samples are shipped to the appropriate vendors, and coordinates with the vendors to ensure samples are assayed and results are received in a timely manner
- Notifies clinical operations of missing samples and participates in the shipment discrepancy resolution process
- Collaborates with clinical operations, subject matter experts, and the vendors to implement central lab specifications
- Drive the implementation of data transfer agreements with vendors in collaboration with data management and subject matter experts.
- Reviews key study start up documents such as clinical study protocols, requests for proposals for laboratory services, contracts and laboratory manuals to verify that biomarker samples are collected as specified in the protocol and related plans.
- Coordinates with data management, IT and subject matter experts to ensure appropriate access and storage of data
- Completes documentation according to cGMP/GLP and all other regulatory agency requirements and archives documents as per applicable policies
- Uses excellent organizational and multi-tasking skills to perform sample management activities, managing timelines and expectations in a cross-functional manner
- May assist with authoring, reviewing and tracking all relevant documents (COCs and stability reports).
- Performs other duties as assigned
- BS or equivalent degree in scientific discipline required. Minimum 4 years of related experience required; direct clinical/biomarker operational experience, with exposure spanning initiation through study completion preferred
- Scientific background in biology or related; knowledge of oncology, immunology and biomarkers preferred
- Excellent organizational and communication skills is essential
- Expertise with one or more Laboratory Information Management Systems (LIMS) strongly preferred
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is required
- Strong verbal and written communication skills
- Proficient knowledge and experience operating within ICH/GXP/GLP/GDP guidelines
- Experience working in a matrix environment, with competing priorities, managing internal and external expectations and requirements
- Experience holding meetings via video/teleconference and effectively working with colleagues remotely
- Collaboratively work in a cross-functional team and fast paced-environment as well as ability to interact with various levels within the organization and external vendors
How to Apply
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to firstname.lastname@example.org.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.