"Regulatory Affairs Specialist-CC"

Job Description

Posted Job Title: Regulatory Affairs Specialist-CC

Job Profile Title: Clinical Research Regulatory Specialist B

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 One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding.

The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Specialist-CC to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, 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, with minimal supervision, 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 Regulatory Affairs Specialist-CC 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 Regulatory Affairs Specialist-CC is expected to facilitate 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 facilitate 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, 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) required, and 3-5 years research experience or equivalent combination of education and experience is required; at least 1 year's regulatory experience preferred. Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred. Associated research credentialing (CCRP, CIP, etc.) preferred.

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. ACC 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, State: Philadelphia, Pennsylvania

Department / School: Perelman School of Medicine

Pay Range: $62,000.00 - $70,119.00 Annual Rate

To apply, visit: https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/3930-Chestnut-Street/Regulatory-Affairs-Specialist-CC_JR00114718