Project Coordinator - Regulatory Support Services

Project Coordinator – Regulatory Support Services

Join the transformative team at City of Hope , where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. 

Under the supervision of the Project Coordinator Manager, the Project Coordinator (PC) provides support to the Clinical Trials Office (CTO) in the coordination, implementation and management of administrative and regulatory duties in the department.

The PC will be responsible for the administration and maintenance of Disease/Modality (D/M) Team meetings for which they are assigned. This includes, maintaining the schedule, agenda, minutes and administrative follow-up. The PC will initiate tracking and the study activation task lists for studies which are endorsed at the D/M Team meetings. They will be responsible for completion and management of regulatory documents for industry and other sponsors, such as, FDA Form 1572, financial disclosures, protocol cover pages, and other documents required for study start up and maintenance. The PC manages and maintains the regulatory binder to ensure that all required documents are filed accordingly (in collaboration with the research staff). The PC maintains sponsor monitor visit logs; downloads approval documents from the Western Institutional Review Board (WIRB) website and uploads them into iRIS (the internal electronic committee management program at City of Hope); coordinates study start up activities which include scheduling of site initiation visits (SIV). Maintains and updates he Investigator Brochure (IB) library.

As a successful candidate, you will: 

• Schedule D/M Team meetings according to institutional policy.
• Ensure meetings have appropriate formats or locations for efficiency.
• Complete and distribute D/M Team agendas before meetings.
• Take accurate meeting minutes and distribute them.
• Communicate meeting cancellations or location changes promptly.
• Adhere to established D/M Team meeting schedules and complete administrative follow-up tasks.

Your qualifications should include: 

• Bachelor’s Degree; or AD/GED with 2 years clerical or similar experience.
• Knowledge of Clinical Research and regulatory forms, preferred.

City of Hope is an equal opportunity employer.  To learn more about our commitment to diversity, equity, and inclusion, please click here .

To learn more about our Comprehensive Benefits, pleaseCLICK HERE .