Will be responsible for all aspects of clinical research regulatory compliance, including document preparation, submission, and management, for a specified portfolio of clinical trials.
- Coordinate the preparation and timely submission of regulatory documents to the City of Hope Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), Data Safety and Monitoring Board (DSMB), other internal committees, national cooperative groups, industrial clinical research sponsors, and Contract Research Organizations (CRO’s) as necessary to meet all internal and external regulatory compliance standards. Responsibilities include, but are not limited to:
- Initial review of research protocols and informed consent documents:
- Preparation and submission of protocol amendments, continuations, adverse events, and document addendums
- Assistance with FDA and NCI submissions in collaboration with other City of Hope departments and Regulatory Affairs Offices.
- Assist in gathering information from Study Coordinators, Physicians, other staff, and study sponsors as needed for the submission of regulatory documents.
- Assists Regulatory Manager with aspects of the research trials regulatory process to include:
- Prepare routine protocol status reports for the CTO office, Investigators, and research staff.
- Oversee and maintain documentation of correspondence to and from the IRB.
- Assist COH researchers in study design, consent form creation and compliance with IRB requirements.
- Communicate to CTO staff relevant aspects of the regulatory process and requirements for protocol development and conduct of research trials.
- Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.
- Assist with updating the medical and CTO staff with regards to institutional requirements for protocol development and conduct of research trials.
Job descriptions are not intended, and should not be construed to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job.
Internal Contacts: Office of Clinical Research Quality Assurance (OCRQA), Cancer Protocol Review and Monitoring Committee (CPRMC),Data Safety and Monitoring Board (DSMB), Department of Clinical Research Information Management (CRIM), Office of Research Subjects Protection, Office of Clinical Trials Finance (OCTF), General Clinical Research Center (GCRC), Nursing Support, Medical Center Physicians, Medical Center Support Services, Information Technology Services (ITS)
External Contacts: Industry, NCI, Cooperative Groups, Consortiums, Other participating institutions, Contract Research Organizations (CRO).
Budget/Financial Administration: Submits all supporting financial documents to the Office of Clinical Trial Finance for budget preparation and contract negotiations.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code 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:
- Bachelors’ degree in Biological Science, Social Sciences, English, or other related field. Experience may substitute for minimum education requirements.
- Minimum of three years of experience related to the management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
- Computer skills including MS Office products, Internet, and general computer proficiency required. Excellent skills in time management, prioritization, and multi-tasking required.
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 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.
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