Summary

The Senior Clinical Research Associate (CRA) will support the Principal Investigator (PI) in conduct of single institution and multi-institution clinical trials of cell therapy. The CRA will coordinate patient screening and research sample collection from different institutions, plan/oversee laboratory testing of clinical-grade cellular products manufactured and prepare documents/cellular product for infusion. The CRA will be responsible for all internal and external communications related to manufacturing and shipping of cellular products and preparing/maintaining all pertinent documents. The CRA will review external Standard Operating Procedures (SOPs), and develop/implement new trial-related SOPs working directly with the study Principal Investigators (PIs) and GMP/GLP facility.

Plays a central role in successful implementation and reporting of single institution and multi-site clinical trials of cell therapy trials for pediatric cancers.

The ideal candidate will be knowledgeable about cGMP guidelines (training preferable), be familiar with cancer biology, immunotherapy and other medical terminologies, is familiarwith collecting and analyzing flow cytometry data, has knowledge of developing and implementing SOPs, has knowledge of MS Office and Prism software, has excellent time management skills, isable to manage multiple projects and diverse tasks, and has communication skills needed to work with different external teams.

Job Duties

Co-ordination and conduct of clinical research (effort – 60%)

• Works with the study team and the Pathology Research Laboratory in tumor testing for eligibility screening. Prepare and maintain required documents (including tumor screening results) as per regulatory (HIPAA compliant) and the clinical trial protocol guidelines.
• Will be responsible for managing all supplies needed for tumor screening, peripheral blood procurement from multiple institutions (including the multi-site trial), laboratory release testing of cellular products, and collection/processing of clinical research samples. Prepare and maintain all pertinent documents.
• Develops and implements trial-specific SOPs working directly with the study PI and GMP/GLP. Works with the study PI in reviewing external GMP and cell infusion related SOPs.
• Tracks all internal and external research samples - create/maintain the sample log and ensure clear communication between treating sites, study team and GLP.
• Collection and processing of CSF and tumor samples. Coordinates these procedures between Pathology, RTSS, GLP and research collaborators
• Participates in clinical trial meetings.
• Acts as a central liaison between the study PIs, research coordinators, Pathology team, external sites, GMP and GLP. Monitors all internal and external samples and maintains a clear communication related to shipped samples/products in real time.

Data gathering, analysis and compilation (effort – 20%)

• Prepares cell infusion documents for institutional and multi-site trials. Work with study investigators in preparing and infusing cells at our site. Trains others in thawing and infusion of cells.
• Prepares documents and coordinates shipping of clinical-grade products to external sites.
• Creates and maintains clinical trial patient log and individual folders with all required information (HIPAA compliant)
• Prepares, collects, and maintains documents for internal and external regulatory bodies.
• Assists study PIs in preparing and maintaining documents required for new IND submission and annual reporting.
• Works with the PI on completing pre-IND studies and compiling the data. Must be familiar with pre-clinical and clinical data required for IND submission to the FDA.

Supervision and training of junior members in clinical/translational research work (effort – 20%)

• Oversees laboratory release testing of cellular products manufactured for infusion on clinical trial(s). Prepares and maintains pertinent documents and train others in implementing these tasks.
• Effectively prioritizes tasks and adapts to changing priorities based on the expected or unexpected external scenarios or change in patient's clinical status.
• Trains junior members of the research team in implementing above outlined task.
• Performs other duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Master's degree in the field of Biology.
• Prior experience in cancer research, conduct of clinical trials, & IND preparation.