Excellent opportunity for a Protocol Development Coordinator at City of Hope!
Apply Online: http://chc.tbe.taleo.net/chc06/ats/careers/requisition.jsp?org=CITYOFHOPE&cws=1&rid=5994
Job Title: Protocol Development Coordinator
Position Summary and Key Responsibilities:
The Protocol Development Coordinator is an integral part of the clinical research team, primarily responsible for assisting investigators with the development, writing and maintenance of investigator-initiated clinical trials protocols. This position will provide support to the interdisciplinary disease teams collaborating with individual investigators to produce high quality clinical trials assuring compliance with federal regulations.
- Responsible for developing the non-scientific portions of a standard research protocol. Responsible for gathering background information from various sources. Collaborate with the investigator and others both within COH and external to COH (pharmaceutical or academic sponsors) to draft non-scientific/clinical aspects including project scope. Entails expansion of the treatment plan from limited information. Review the entire protocol document for consistency, clarity, formatting and grammar. May assist with Letter of Intent and Informed Consent Form development. Develops new studies.
- Serves as primary contact for revisions to the protocol document during the submission and approval processes (including funding source, FDA, CPRMC and/or IRB). Edit documents with future revisions/amendments to the study. Prepares the summary of changes and may respond to any queries about the changes during the approval process.
- Monitors the trial status and responds to inquiries from regulatory committees, affiliates, disease teams, CTU staff, etc.
- Critically reviews investigator initiated protocols submitted for disease team endorsement and provides constructive feedback to principal investigator and the respective disease team regarding the submission ready status of the protocol.
Performs other related duties as assigned or requested such as presentation of draft ideas and plans to investigators, coordination of meetings required to create collaborative interactions both within and outside City of Hope, and reporting of progress to Principal Investigators.
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:
- Master’s Degree. In lieu of a Master’s degree, a minimum of 5 years of relevant writing and regulatory compliance is required.
- Three or more years of clinical protocol writing experience, preferably in a healthcare/research/academic environment.
- A solid understanding of the clinical development process, including the documents that are required at each stage of development.
- Experience with IND applications and clinical protocols, preferred.
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, age, status as a protected veteran, or status as a qualified individual with disability.
Regards,
Darlene Blount
Talent Acquisition
City of Hope
Email: xxxxxx@coh.org
Direct Line: (626) 218-0343
Internal: 80343
Web: www.cityofhope.org/careers
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