Protocol Development Specialist
- Duarte, CA
Thank you for your interest. Please note, the purpose of this posting is to recruit for on-going and future positions.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.
The Protocol Development Specialist (PDS) is an integral part of cutting-edge research at City of Hope. He/she is primarily responsible for assisting clinical researchers, under the direction of the Office of Clinical Protocol Development (OCPD) Senior Manager, with developing, writing and editing clinical research protocols. The research subject matter is very broad and may include but is not limited to first-in-human agents, novel applications or combinations of FDA approved agents, surgical and other devices, screening and diagnostic tools, molecular biomarkers, quality of life, risk factors and imaging.
Key Responsibilities include:
- Assists the investigator(s) with developing, writing and editing non-scientific portions of clinical research protocol documents. Documents may include protocol associated materials (such as letters of intent, consent documents, patient materials, etc.).
- Works collaboratively, via in person and virtual meetings, phone calls and emails, with investigators, biostatisticians, study team members, regulatory and operational staff, to develop and/or coordinate the development of the clinical research documents.
- Expands non-scientific areas of the protocol from limited information and with minimal direct supervision. Reviews and edits the background section of the protocol provided by the investigator(s).
- In partnership with and at the behest of the investigator(s), communicates with sponsors or academic partners to obtain protocol template and reporting language, as well as to facilitate study development, review and approval.
- Reviews draft protocol documents for content, consistency, clarity, formatting, and grammar to ensure they are submission ready.
- Provides excellent customer service by producing documents and responding to communications in a timely manner.
- Develops informed consent documents or reviews and edits informed consents developed by Research Support Services
- In partnership with, and at the behest of the investigator(s), coordinates and/or responds as needed during the protocol document submission and approval process to reviewer's (sponsor, FDA, scientific review committee, IRB, etc.) comments and stipulations. May involve seeking clarification from relevant parties, revising documents and drafting initial responses to queries/comments.
- Interfaces and coordinates with Research Support Services, the Office of IND Development and Regulatory Affairs and other internal stakeholders to ensure version control and timely movement of the study through committees.
- Contributes to the development of the PDS team logistics, operations, and knowledge base.
- Participates in other PDS functions, which may include:
- Critical assessment/review of non-PDS developed protocols and LOI's.
- Updating the clinical protocol template maintained by PDS.
- Regular team meetings and training.
- Collaboration with research oversight committees and other internal stakeholders to improve the clinical protocol review and approval process.
Basic education, experience and skills required for consideration:
- Master's degree with 1 or more years of relevant experience or a Bachelor's degree with a minimum of 3 years of relevant experience.
- Relevant experience must include at least one of the following:
- Development and/or use of clinical research protocols
- Writing of research protocols and/or grants
- Regulatory work involving clinical protocols and development of informed consents
Preferred education, experience and skills for consideration:
- Doctorate in biology, other life science, public health or research related discipline with a familiarity of the following: oncology, epidemiology, biostatistics, clinical research, regulatory science, healthcare/medicine.
- A background or knowledge within research study/experimental design, medical terminology, informed consent/clinical trial screening processes, adverse event collection/reporting and clinical protocol review and approval process
- Experience writing clinical trial protocols.
- Experience with the development, implementation or execution of single or multi-center clinical research studies.
- Familiarity with federal regulations and guidelines pertaining to interventional and non-interventional clinical research, including studies done under IND applications.
- CCRP, ACRP or equivalent certifications are preferred but not required
- Posting Date: Jul 2, 2021
- Job Field: Clinical Research
- Employee Status: Regular
- Shift: Day Job
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