Staff Scientist - Diamond Lab
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 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.
Requisition ID: 12852
Job Title: Staff Scientist Protocol Writer
Position Summary and Key Responsibilities:
Investigator-initiated clinical studies are critical to translate scientific discoveries into medical advances. The Department of Experimental Therapeutics, at City of Hope National Medical Center, is looking for a scientist to provide writing and regulatory support for their CMV and Oncology clinical trials. Under the direction of Dr. Don Diamond, the successful candidate will work closely with the clinical study teams and regulatory personnel. The ideal candidate will have an oncology or immunology background and clinical trial experience. However, other suitably qualified candidates will be considered. Good oral and written communication skills are essential for this post.
The incumbent will:
- Draft and submit Clinical Trial Documents (CTDs), including clinical protocols (CPs), consent forms (CFs) and Investigator's Brochures (IBs).
- Manage amendments to CTDs as required by the study team, Research Committees and FDA.
- Provide writing support as required by the department e.g. study reports, grant applications and manuscripts.
- Act as a contact for external trial sites.
- Use City of Hope document templates to draft CPs, CFs and Ibs.
- Interact with study statisticians, scientists, oncologists, regulatory staff and other personnel to ensure accuracy and standard of final CTDs.
- Complete online applications for clinical studies (using IRIS).
- Manage all CTD amendments as required by the study team, research committees and FDA.
- Act as a contact for external trial sites and respond to their enquiries.
- Contribute to grant applications, manuscripts, presentations and annual study reports as required.
Minimum Education and Skills Required for Consideration:
- The Staff Scientist must possess, at a minimum, the U.S. equivalent bachelors or master's degree in Biomedical discipline or other relevant subject, and will often have a Ph.D. or other doctoral level degree.
- Demonstrated scientific writing ability e.g. lead author on original manuscripts and reviews
- Proficiency in Microsoft Word, PowerPoint, Endnote and Excel
- Experience using Biomedical search engines e.g. PubMed
- An interest in clinical research
- Comfortable working independently or collaboratively
- Knowledge of clinical research concepts, terminology, regulations and methods gained from working in a clinical research environment.
- Scientific background in oncology and/or immunology.
- Experience writing CTDs for investigator-initiated studies and submission to review boards, FDA or other committees.
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.