Summary

We are looking for an experienced individual to manage two exciting clinical studies related to testing of newborns for their risk of childhood cancer by DNA sequencing.  These studies will use state-of-the-art genomic methods and include multiple hospitals in Texas and Massachusetts.  The successful candidate will work with the principal investigators on developing the clinical trial protocol, manage the IRB submission process and work with colleagues here and in Boston on carrying out the trial. 

This individual will be responsible for overseeing the clinical trials associated with the Alex’s Lemonade Stand Foundation (ALSF) Crazy 8 grant (entering Year 2 of a four-year project) and the CPRIT INSPECT grant (entering Year 1 of a three-year project).

They will collaborate closely with the principal investigators to develop clinical trial protocols for both projects and will manage the submission of these protocols through BRAIN, including coordinating and implementing any required revisions.

In addition, this individual will develop standard operating procedures (SOPs) for both trials to ensure consistent and compliant execution.

For the Crazy 8 grant, they will work closely with collaborators in Boston to support the approval process at Brigham and Women’s Hospital.

They will also assist with the preparation and submission of annual progress reports to ALSF and CPRIT.

Job Duties

• Assists with development of clinical trial protocols for the N-CARE and INSPECT clinical trials, manage submission of protocols to IRB, provide any needed modifications and oversee annual reporting to the IRB. 
• Develop protocol Standard Operating Procedures and update as needed. 
• Work with clinical coordinators on monitoring recruitment of subjects.
• Organize clinical trial team meetings. 
• Manage ongoing assessment of completion of clinical trial goals.
• Manage annual reporting to the funding agencies. 
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Experience coordinating or managing clinical trials, particularly in genomics or early detection studies.
• Familiarity with protocol development and regulatory submission processes (e.g., BRAIN or similar IRB systems).
• Experience developing standard operating procedures (SOPs) for clinical research.
• Knowledge of newborn screening, genetic testing, or cancer risk assessment.
• Experience working on multi-institutional collaborations, including coordination with external sites.
• Strong organizational skills with the ability to manage multiple grant-funded projects simultaneously.
• Experience supporting grant reporting and progress updates for funding agencies (e.g., ALSF, CPRIT).
• Effective communication skills and ability to work closely with principal investigators and research teams.