Protocol Development Specialist( Medical/Scientific Writer)-Remote

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.

Position Summary

**This is a remote opportunity **

The Protocol Development Coordinator (PDC) is an integral part of cutting edge research at City of Hope. He/she is primarily responsible for assisting researchers with developing, writing and editing investigator-initiated clinical research protocols and clinical trial protocols. Research protocol subject matter is very broad, involving trials studying first-in-man agents, surgical instruments and diagnostic tools, and research studies examining molecular biomarkers, quality of life, and risk factors for disease.

Key Responsibilities include:

• Assists the principal investigator with developing, writing and editing non-scientific portions of investigator-initiated clinical research/trial protocol documents. May include their associated materials (letters of intent, consent documents, patient materials, IRB application, etc.).
• Works collaboratively with study team members and regulatory and operational staff, to develop or coordinate the development of the study design and protocol required information.
• Expands non-scientific areas of the protocol document from limited information and with minimal direct supervision.
• In partnership with and at the behest of the principal investigator, may communicate with pharmaceutical or academic partners to obtain and facilitate operational language.
• Reviews the entire protocol document for content, consistency, clarity, formatting, and grammar to ensure a submission-ready document.
• In partnership with and at the behest of the principal investigator, coordinates and/or responds as needed during the protocol's submission and approval processes (industry partner, FDA, scientific review committee, IRB). May involve seeking clarification from relevant parties, revising documents and drafting initial responses to queries/comments.
• Contributes to the development of the PDC team logistics, operations, and knowledge base.
• Participates in other PDC functions, which may include:
  • Critical assessment of non-client investigator-initiated protocols submitted for disease team endorsement; provision of constructive feedback to the principal investigator and the respective disease team regarding the submission-ready status of the protocol.
  • Initial consultation with investigators regarding their projects.
  • Outreach to the COH community regarding PDC services.

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.

Basic education, experience and skills required for consideration:

• Master's degree. Or in lieu of a master's degree, a bachelor's degree with a minimum of 3 years of relevant experience.
• 1 or more years of relevant experience.
• Relevant experience must include at least one of the following:
  • development and/or use of research protocols (animal protocols, clinical research studies, or clinical trials)
  • writing of research protocols and/or grants
• Knowledge of:
  • clinical protocol review and approval process
  • basic biology
  • research study/experimental design

Preferred education experience and skills:

• Doctorate in biology, biochemistry, or other life science.
• Experience writing clinical trial protocols.
• Coursework or working familiarity of the following: immunology, physiology, oncology, endocrinology, genetics, epidemiology, biostatistics.
• Experience with development, implementation or execution of investigator-initiated pharmaceutical-funded studies or multi-center trials.
• Familiarity with federal regulations and guidelines pertaining to interventional and non-interventional clinical research, including IND applications.

Additional Information:

To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

City of Hope is committed to creating a diverse environment and is proud to be 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. #LI

• Posting Date: Oct 4, 2021
• Job Field: Clinical Research
• Employee Status: Regular
• Shift: Day Job