Job Description
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.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
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.
Essential Functions:
- 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.
- Serve as the primary contact for general status inquires for new studies in assigned D/M Team.
- 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
Your qualifications should include:
Minimum Education: Bachelor’s Degree; or AD/GED with 2 years clerical or similar experience.
Preferred Education: BA/BS degree.
Preferred Experience: Knowledge of Clinical Research and regulatory forms.
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, please CLICK HERE.
Salary / Pay Rate Information:
Pay Rate: $26.81 - $41.55 / hour
The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.
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