Project Coordinator,Regulatory Support Services
- Duarte, CA
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers that develops and institutes standards of care for cancer treatment.
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.
Key Responsibilities include:
- Schedule D/M Team meetings according to current institutional policy.
- Ensure meeting has appropriate format or location to be conducted in an efficient and appropriate manner with adequate resources (i.e. web conference, or teleconference or in-person meeting room is booked).
- Ensure D/M Team agenda is completed according to institutional timelines and distributed to team members prior to the meeting.
- Take or transcribe D/M Team meeting minutes and ensure accuracy, completeness and distribution according to institutional policy.
- Ensure timely communication regarding meeting cancellations or location changes.
- Adhere to the established D/M Team meeting schedules.
- Ensure any administrative follow-up from D/M Team meetings is completed, such as communication with members, updates of open issues, or notifications to Sponsor Relations or Community Practices.
- Coordinate with Senior Regulatory Coordinator updates for D/M Team meetings.
- Ensure study is established in Initiate the task list in the clinical trials management system (CTMS) in order for the activation timeline to start.
- Ensure regulatory binder is created in the e-regulatory platform according to institutional standards.
- Ensure sponsor directed regulatory platforms are established and up-to-date.
- Complete and manage 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.
- Coordinate and schedule study initiation visit (SIV) for the Duarte campus.
- Maintain regulatory files and ensure completeness for assigned trials. This includes filing and ensuring essential documents are up-to-date.
- Maintains and updates the investigator brochure (IB) library.
- Coordinate and schedule close out visits (COV) for the Duarte campus.
- Ensure study master file (SMF) is archived according to institutional policy.
- Participate in quality improvement activities
Basic education, experience and skills required for consideration:
- Bachelor’s Degree; or AD/GED with 2 years clerical or similar experience.
- BA/BS degree.
- Knowledge of Clinical Research and regulatory forms
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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