Regulatory Affairs Specialist II

City of Hope

Duarte, CA

Job posting number: #7230368 (Ref:10025230)

Posted: March 21, 2024

Salary / Pay Rate: $38.11 - $59.07 / hour

Application Deadline: Open Until Filled

Job Description

Join the forefront of groundbreaking research at theBeckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

A Regulatory Affairs Specialist II position is available in the Diamond Research Laboratory. You will assist and support internal and external PIs, for timely and accurate submissions related to clinical protocols under their jurisdiction. This may also include preparation, review, and compilation of Investigational New Drug Application (IND) Annual Reports; protocol review for protocol amendments along with review of documentation for informational amendments, and review of safety documentation. In preparation for these submissions, you 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. You will also assist with regulatory maintenance, amendments/approvals (IRB, IBC, and IACUC), training documentation, etc. to ensure regulatory compliance.

As a successful candidate, you will:

· Lead in the design and development of clinical protocols, consent forms, SOPs, and other documents required by the project.

· Ensure compliance with protocol, regulatory and overall clinical and quality objectives.

· Compose, edit or review laboratory SOPs, and review/revise manufacturing and quality testing SOPs.

· Write pre-clinical and clinical documents, handle submissions for iRIS and respond to regulatory authorities.

· Communicate critical information related to project timelines and core project teams.

· Act independently to determine methods and procedures of new projects.

Qualifications:

· Bachelors degree in a scientific discipline or equivalent with a Masters degree preferred.

· 2-5 years of regulatory affairs experience with a Bachelors or 0-2 years of regulatory affairs experience with a Masters

· Preferred experience within regulatory affairs, clinical trials management or relevant scientific field

· RAPS, SOCRA or ACRP Certification is preferred but not required

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please click here

Salary / Pay Rate Information:
Pay Rate: $38.11 - $59.07 / hour

The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.



City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.


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