Project Coordinator RSS
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
City of Hope strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced. City of Hope is 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.
Requisition ID: 10468
Job Title: Project Coordinator - RSS
Position Summary and Key Responsibilities:
The project coordinator provides support to the Regulatory Support Services (RSS) in the coordination, implementation and ongoing evaluation of all phases of projects in the department.
The project coordinator will be responsible for the completion and management of regulatory documents for industry and other sponsors such as FDA Form 1572, financial disclosures and other documents required for study start up and maintained throughout the life cycle of the study; manage and maintain the regulatory binder to ensure that all required documents are filed accordingly (in collaboration with the research staff); maintain sponsor monitor visit logs; managing the department email and phones; logging in work on the RSS monitoring system; creating agendas and recording minutes for the RSS staff meetings; downloading approval documents from the WIRB website and uploading them into iRIS (the internal electronic committee management program at City of Hope); administrative amendments (as needed) per the direction of RSS Operations Manager; Coordinates study start up activities which include scheduling of site initiation visits (SIV); coordinates the Research Protections Unit (RPU)/Clinical Trials Office (CTO) training for staff; maintain the RSS website on the COH intranet and manage the Investigator Brochure (IB) library.
- Serve as the primary contact for general status inquires, manage and triage RSS new work submissions using the RSS workload monitoring system and process all WIRB documents.
- Coordinate regulatory documents submission, including collection, completion and maintenance required for new studies. Provide status updates to study teams.
- Process administrative only amendments as per the direction of RSS Operations Manager for all studies.
- Create agendas and record minutes for RSS staff and other meetings.
- Participate in quality improvement activities.
- Maintain RSS website on intranet, including forms, guidance documents and FAQ's.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- BA/BS degree, experience may substitute. BA/BS degree is preferred.
- 2 years of experience.
- Knowledge of Clinical Research and regulatory forms is preferred.
- Professional demeanor, critical thinking, excellent communication and organizational skills to work with a wide audience.
- Excellent verbal communication and telephone skills.
- Excellent written communication skills.
- Work well in a team setting,
- Experience with MS Word and Excel is required, experience with PowerPoint, Acces, and MS Project or other project management software is preferred.
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