Project Coordinator RSS

City of Hope; United States; On-site; USD 45,000 - 65,000; Full time

Job summary

City of Hope’s Clinical Trial Office (CTO) seeks an organized Project Coordinator to support regulatory duties, initiates and maintains study documentation, and coordinates investigator activities across multiple trials. The role requires attention to timelines, accuracy in documentation, and effective communication with sponsors and internal teams.

Responsibilities include scheduling D/M Team meetings, preparing agendas, maintaining CTMS task lists, and ensuring regulatory binders are

Qualifications

• Bachelor’s Degree or AD/GED with 2 years clerical or similar experience.
• Preferred BA/BS degree.
• Knowledge of Clinical Research and regulatory forms.

Responsibilities

• Schedule D/M Team meetings and ensure proper format/location.
• Record and distribute meeting minutes in a timely manner.
• Coordinate regulatory binders and sponsor regulatory platforms.
• Maintain and update regulatory files and essential documents.
• Coordinate and schedule study initiation visits (SIV) and close out visits (COV).
• Ensure study master file is archived according to policy.
• Support quality improvement activities.

Education

Bachelor’s Degree or AD/GED with 2 years clerical or similar experience

BA/BS degree

Job description

scription - External
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.

Position Summary

The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. Under the direction of the Portfolio Supervisors, Senior Director, Clinical Trial Office and the CTO leadership team with input from the Disease Team Chairs and the Study Investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases. 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 form

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

City of Hope is an equal opportunity employer.