Clinical Study and Biospecimen Coordinator

Vyriad•Rochester, MN

41d•$52,000 - $67,000

About The Position

The Clinical Study and Biospecimen Coordinator (CSC) plays a key role in supporting the operational execution of Vyriad's Phase 1/2 clinical trials and will be responsible for managing biospecimens used for exploratory and translational research. This position is critical in coordinating supply of test kits and receipt of clinical samples, ensuring high-quality sample collection, processing, shipping, tracking, and documentation across a network of clinical sites and research laboratories. The candidate will maintain sample inventory, receive data reports and be responsible for data entry and analysis. The CSC will collaborate closely with Clinical Operations, Translational Science, external vendors, and clinical sites to maintain compliance, ensure protocol adherence, and facilitate timely generation of high-quality data.

Requirements

Bachelor's degree in Life Sciences or related field; Masters degree a plus but not required
2+ years of experience in clinical research or clinical operations, ideally within a biotech or early-phase trial environment
Working knowledge of GCP/ICH guidelines, clinical trial conduct, and regulatory documentation
Strong understanding of specimen types (e.g., whole blood, serum, plasma, PBMCs, tumor tissue) and proper collection/processing requirements
Highly organized with the ability to manage multiple tasks simultaneously across studies
Strong communication and interpersonal skills for effective collaboration with internal central lab staff, clinical operations team members, vendors, and site staff
Detail oriented with excellent documentation, tracking, and problem-solving abilities
Ability to adapt quickly and work effectively in a fast-paced, dynamic environment.
Strong problem-solving skills with the ability to navigate ambiguous situations and make sound decisions.
Proficiency with EDC systems, LIMS/sample-tracking tools, and Microsoft Office tools
Must be able to lift up to 15 pounds at times.
Prolonged periods of sitting at a desk and working on a computer.

Nice To Haves

Prior hands-on experience with biomarker operations (eg. biospecimen handling, central lab coordination, translational research workflows, etc.) strongly preferred
Familiarity with oncology Phase 1/2 study designs, PK/PD sampling and data evaluation desirable

Responsibilities

Assist in day-to-day oversight of multiple ongoing Phase 1/2 trials, supporting study start-up, conduct, and close-out activities
Maintain and update study trackers, timelines, enrollment metrics, and essential documentation
Support preparation, review, and approval of study materials (e.g., site training slides, study manuals, sample handling guides, visit worksheets)
Coordinate and document study team meetings, vendor meetings, and cross-functional check-ins
Monitor site performance metrics and assist with issue identification, follow-up, and escalation
Work with CROs, central labs, and vendors to ensure deliverables are met according to the study plan
Support data review activities such as data listings checks, lab reports reconciliation, and query management
Serve as the primary operational contact for test kits, biospecimen collection, processing, and logistics across clinical sites
Ensure all sample-related procedures follow protocol requirements, sample manuals, IATA regulations, and GCP guidelines
Track and log daily/weekly sample collections, deviations, processing results, and shipments using internal LIMS system and eCRF
Coordinate shipment logistics including temperature-controlled handling, courier pickup scheduling, and documentation
Receives correlative research data reports and ensures data entry and analysis
Work closely with patient management and operations teams at clinical sites to align sample workflows with central lab biomarker analysis needs
Maintain complete, accurate sample chain-of-custody records and promptly address discrepancies
Support biorepository activities such as inventory reviews, sample labeling audits, and sample reconciliations
Assist in onboarding and training clinical sites on biospecimen handling procedures, including updates to sample manuals and shipping instructions
Additional duties as assigned.