Research Operations Specialist

Location
South San Francisco, CA
Posted
Apr 13, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

LOCATION: South San Francisco

DEPARTMENT: Research & Translational Science

DIVISION: Research & Translational Science

REPORTS TO: Senior Director, Translational Science

SUMMARY: 

Day One Biopharmaceuticals is seeking a Research Operations Specialist. This position will be responsible for working with translational and clinical research leads to manage implementation of preclinical studies and translational research components of clinical trials.

Regarding preclinical research, this individual will be responsible for managing inventory for research and development programs, including compounds and study tracking. On the clinical side, the Research Operations Specialist will bring operational and strategic expertise to the clinical study team in order to ensure success in this critical aspect of our clinical trials. This includes responsibility for the planning, coordination, and maintenance of all operational activities for clinical biospecimen management, oversight of clinical sample shipment and reconciliation, tracking the execution of biomarker testing for early and late-stage clinical trials, and managing timelines and data transfer to align with the clinical trial schedule.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Work with research leads to ensure implementation of preclinical and nonclinical studies including compound shipments, assigning and tracking of internal study numbers, and tracking research study progress
  • Work with clinical leads to oversee entire clinical trial biospecimen process from kit assembly to clinical sample collection, from shipment to receipt and tracking, storage, inventory maintenance, and destruction
  • Ensure efficient R&D research specimens operations across all functional areas
  • Manage sample retention times according to trial informed consent parameters
  • Participate in outsourcing activities to CROs, including vendor selection and scope of work development, execution and tracking of contracts; and review of budgets and timelines
  • Manage patient sample analysis, reconciliation against study visits, and data transfer
  • Adhere to ICH/GCP, HIPAA, biorepository, and biospecimen management best practices
  • Author biomarker relevant sections in clinical study documents and systems
  • Provide sample and assay status updates to project team and help build and maintain dashboards and modern tracking systems
  • Work collaboratively in cross-functional, fast-paced, regulatory-rich environment

 

EDUCATION/EXPERIENCE/SKILLS: 

Education:

  • Life sciences degree (BS or MS) in scientific or clinical discipline

Experience:

  • 3+ years’ experience in technical research, project management or clinical logistics role
  • Experience in sample management preferred

Knowledge/Skills/Abilities:

  • Experience in GLP, GMP and/or GCP regulated environments and studies
  • Experience working with colleagues remotely
  • Experience in project management and working in matrixed clinical study teams preferred
  • Superior written, verbal communication, organizational and people skills
  • Highly collaborative and a strong team player

 

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.