Staff Scientist - Regulatory Affairs

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.

Position Summary
The position is responsible for regulatory affairs support for pre-clinical and clinical trials conducted by Dr. Diamond's group at City of Hope National Medical Center.

Responsibilities Include:

• Draft, edit and review pre-clinical and clinical (Phases I-III) protocols, Investigator Brochures, Institutional Consent Forms, and related regulatory documentation.
• Amend and submit regulatory documentation to internal and external committees; review according to needs and requirements of the clinical group, PI, scientific group, field medical personnel, biostatistician and other parties involved in conducting clinical trials
• Ensure that submission deadlines for new protocols, amendments, renewals, etc. are met.
• Comply with all applicable internal and external regulations, including human subjects' protections, HIPAA, GCP, GLP and GMP.
• Participate in NCI-mandated Disease Team meetings to support ongoing clinical trials sponsored by Dr. Diamond's group.
• Participate in clinical and scientific teams' meetings related to Diamond group protocols, contribute to discussions on existing trial interpretation and prospective trial design.
• Collaborate with the Regulatory Office personnel in preparing FDA documentation, including reports and submissions.
• Collaborate with Clinical Research Coordinators and Clinical PIs for respective trials in handling requests for protocol interpretation and amendments according to the needs of the clinical team.
• Collaborate with Biosafety Office to ensure that biosafety requirements are met by all research conducted by Diamond group.
• Serve as a point of contact for the clinical team, external collaborators, pharmacy, regulatory office, internal and external committees.

Qualifications
Basic education, experience and skills required for consideration:

• Ph.D. or M.D/Ph.D. degree in Biological, Biomedical Science or related degree
• Experience using Windows, MS Office, and MS Teams
• Experience using IRIS, Salesforce, and/or EndNote is preferred

Additional Information:

• For more information on Dr. Don Diamond's research please visit, here

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.