Research Protocol Analyst - Data and Safety Monitoring Committee

City of Hope

1d

About The Position

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
The department of Clinical Research Protections is looking for a Research Protocol Analyst who provides administrative, regulatory and operational support to the Data and Safety Monitoring Committee (DSMC). You will manage a portfolio of human research protocols from initial submission through the protocol’s life cycle, ensuring that protocols are reviewed appropriately by relevant committees. Accordingly, you should be familiar with the human subject protection regulations set forth at 45 CFR 46 and 21 CFR Parts 50, 56, 312, 600 and 812 and other federal guidance, as well as the cancer center support grant requirements. You will also have frequent interactions with Principal Investigators, study team members, committee members, and other departments involved in the review, approval and oversight of research conducted at City of Hope facilities or by its employees or agents.
As a successful candidate, you will:

Requirements

• Bachelor’s Degree in life sciences, information technology, business administration, or related fields. Higher degree preferred.
• 3 years of experience in systems and database management
• Experience with sponsored research management / research operations software systems.

Nice To Haves

• Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), or Certified Clinical Research Coordinator (CCRC) is preferred but not required.
• Strongly preferred prior use of a grant management system
• Experience in sponsored research, academic, research environment or Comprehensive Cancer Center preferred.

Responsibilities

• Shepherd protocols through the DSMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations.
• Be responsible for managing the review of new protocols, amendments, progress reports, monitoring reports, audits, serious adverse events (SAEs), deviations, unanticipated problems and other reportable events.
• Prepare materials for committee meetings for assigned protocol submissions ensuring completeness and supplement the packets with relevant reports, e.g., SAE and deviations reports.
• As requested, assist in preparing materials for internal and external audits and accreditations and ensure assigned protocols are ready with appropriate documentation is filed, current and compliant with internal and external requirements.
• Identify areas for process improvement and efficiencies that also support regulatory compliance.
• Participate as requested in quality improvement initiatives which may include but are not limited to policy and/or procedure development or updates, electronic form revision in iRIS, workflow updates and report and dashboard enhancements to support daily operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level