Clinical Trials, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Currently, we are seeking a Regulatory Affairs Specialist I for our Duarte location. In this role, you will help researchers within the DMRI to develop, write and edit protocols for clinical research studies and trials, which examine everything from diagnostic tools, to molecular biomarkers and risk factors for disease, and novel cell-based therapeutics. In addition to protocol development and review, you’ll coordinate and participate in submission and approval processes.
Requisition ID: 10904
Job Title: Regulatory Affairs Specialist I
Position Summary and Key Responsibilities:
The Regulatory Affairs Specialist I will be responsible for preparing new protocol applications, clinical protocol amendments, deviations, safety reports, exemptions and continuations for review and submission. In addition, will assist with preparing supporting portions of Investigational New Drug Application (IND) filings to include but not limited to: annual reports, protocol amendments, informational amendments, safety reports, and sections of initial filings as requested. In preparation of these filings, individual will be responsible for interacting with internal personnel to include investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), as well as Manufacturing, Quality Control, and Quality Assurance staff. In addition, individual will assist with regulatory maintenance and review of Investigator site files to include Form FDA 1572’s, IRB approvals, training documentation, etc. to ensure regulatory compliance.
Additionally, specialist will be responsible for logistic coordination such as coordinating related meetings, action items, product tracking and planning activities.
Provide assistance and support to Principal Investigators, for timely and accurate submissions related to DMRI clinical protocols. This may also include, but is not limited to, preparation, review, and compilation of new protocol applications, IND Annual Reports; protocol review for Protocol Amendments; review of documentation for Informational Amendments, and review of Safety Reports.
Maintaining investigator regulatory files.
Assists with the preparation of departmental standard operating procedures (SOPs).
Ensure compliance to applicable regulatory and quality policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.
Provides guidance to physicians and principal investigators in the interpretation of applicable regulations and guidelines, to include but not limited to GCP, GLP, ICH, FDA, and NIH OBA guidelines.
Participate in clinical trial adherence evaluations and compliance audits.
May assist in facilitating regulatory agency inspections.
Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in the field of expertise.
Is self-motivated in organizing and following through on assigned projects.
Ensures work environment is organized and functions efficiently.
Attends and participates in meetings as required.
Tolerates flexible work hours to achieve critical deadlines.
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:
Minimum Education: Bachelor’s degree in biology, biochemistry, or other life science.
Minimum Experience: A minimum of 2 years of related experience.
Preferred Courses/Training: Training/Certification in Regulatory Affairs or laboratory experience in relevant scientific field.
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. The City of Hope Diabetes and Metabolism Research Institute (DMRI) is home to a multidisciplinary team of endocrinologists, diabetes immunologists, stem cell biologists, geneticists and other clinical and basic science investigators, who together aim to advance treatment options for and someday cure both type 1 and type 2 diabetes. Several novel cellular and immunotherapies for type 1 diabetes are in development, with multiple clinical trials slated to open in 2018.