"Regulatory Affairs Start-Up Specialist Senior-CC"

Job Description Summary

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 is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Position contingent upon funding.

Job Description

The ACC Regulatory Affairs Office seeks a full-time Senior Regulatory Affairs Start-Up Specialist to independently prepare and process the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the Senior Regulatory Affairs Start-Up Specialist will independently prepare and process all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration with the Regulatory Administrative Coordinator, he/she will 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 Start-Up Specialist is expected to independently resolve regulatory queries, and participate in the initiation of the new study, as well as communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Senior Regulatory Affairs Start-Up Specialist is expected to oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications, and the development of study specific forms and source document tools, as well as, to provide direct regulatory/compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site trials.

Qualifications

• Bachelor's degree preferably in a life science or human subject protection field and 5-7 years of related experience or equivalent combination of education and experience required. Advanced degree preferred. Minimum 4 years regulatory start-up experience required; at least 2 years' experience in the clinical setting (pharmacy, patient care) with interactions across legal, finance, and clinical workflows required. Experience conducting high risk biomedical research required; specific knowledge of oncology interventional research required; previous experience with protocol development and design preferred; previous experience developing and implementing CAPAs required. Research credential (CCRP, CIP, etc.) preferred; required within 2 years of hire.
• 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; advanced 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.

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 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.

Location

Job Location - City, State: Philadelphia, Pennsylvania
Department / School: Perelman School of Medicine

Pay Range

$74,500.00 - $85,907.00 Annual Rate