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Posted Job TitleRegulatory Affairs Specialist Senior (Abramson Cancer Center)(Remote Eligible)Job Profile TitleRegulatory Affairs Specialist SeniorJob Description SummaryThe Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 13 Research Teams that support disease/discipline specific cancer programs within the ACC. Contingent upon funding.Job Description
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 13 Research Teams that support disease/discipline specific cancer programs within the ACC. Contingent upon funding.
The CRU Regulatory Affairs Office seeks a full-time Senior Regulatory Affairs Specialist to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Senior Regulatory Affairs Specialist will, independently prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will, independently prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Senior Regulatory Affairs Specialist is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits. He/she will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Senior Regulatory Affairs Specialist is expected to oversee the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and oversee investigator initiated trials and investigator-initiated multi-site trials. Additional duties relevant to regulatory affairs as assigned.
Qualifications:
The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations, including ICH GCP guidelines. The successful candidate must be self-driven with heightened attention to detail. Candidates must desire to work in a fast-paced environment with competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Candidates must have a high level of general computing ability. Intermediate/expert level of function in all of the Microsoft Office applications, as well as, applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus.
Bachelor’s degree (preferably in a life science or human subject protection field) and 5-7 years research experience or an equivalent combination of education and experience required. Advanced degree preferred. At least 4 years regulatory experience required. Experience conducting high risk biomedical research required; specific knowledge of oncology interventional research preferred; previous experience developing and implementing CAPAs preferred. Associated research credentialing (CCRP, CIP, etc.) preferred; required within 2 years of hire.
Working Conditions:
This position is intended to be largely remote. Candidate must agree to use a remote workspace that is conducive to working, free of hazards and other dangers to people and equipment. Abramson Cancer Center, Clinical Research Unit strongly recommends the candidate set up a separate area. Equipment should be placed where it is adequately supported. The candidate remains obligated to comply with all University rules, policies, practices and instructions that would apply if the candidate were working on the premises of the University. The candidate agrees to ensure arrangements are made for dependent care and confirms non-work related interests will not compete with work requirements during the designated regular work hours. The candidate will be responsible for determining any tax implications of maintaining the remote workspace. The candidate will be responsible for complying with any and all local township codes, rules, regulations, and zoning ordinances which could affect the ability to use the designated remote workspace.
Job Location – City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$61,046.00 – $77,920.00 Annual RateSalary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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