"Regulatory Specialist A (Abramson Cancer Center)"

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.

Regulatory Affairs Office assists in obtaining and maintaining institutional and government approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials. The Regulatory Affairs Specialist A provides high-level, supervised, administrative support for the day to day activities of site associated clinical research such as tracking documents and preparing reports, scheduling and attending meetings, as well as taking and circulating meeting minutes. Responsibilities include acting as the primary coordination liaison with external entities including pharmaceutical companies, contract research organizations (CROs), and government officials to prepare and organize essential regulatory documentation in support of study conduct at the site level. This may include but is not limited to financial disclosure forms, FDA form 1572, protocol signature pages, and study specific training documentation. The Regulatory Affairs Specialist A also provides day to day oversight and coordination of the credentialing information for study associated faculty, research nurses, research coordinators, and ancillary support staff inclusive of credentials such as GCP, HSP, CV, clinical licensure, and profile information. The Regulatory Specialist A may also work in collaboration with study team members to complete reviews of research documentation for quality assurance pertaining to the ongoing approval for research activities. Further, the Regulatory Specialist A may compile sets of documents for study team members to use in future regulatory filings such as IRB/ancillary committee modification and continuing approval applications.

Job Responsibilities

The Regulatory Affairs Specialist A provides high-level, administrative support for the ACC OCCR Regulatory Affairs Office. This position directly reports to the ACC Regulatory Affairs New Study & Continuing Review Manager. Responsibilities include acting as the primary on-site liaison with external entities including pharmaceutical companies, contract research organizations (CROs), the NCI Cooperative/Clinical Network Groups to prepare and organize regulatory documentation for study start up day to day oversight and coordinating the credentialing information for associated faculty, research nurses, research coordinators, and ancillary support staff inclusive of both internal credentials such as CITI/GCP, and person profiles in Veeva SiteVault; completion of regulatory quality assurance documentation pertaining to the ongoing approval for research activities; Completion of regulatory quality assurance documentation pertaining to the ongoing approval for research activities; process and file necessary documentation related to protocol specific study team training at the time of initial protocol activation, on-going study updates, and interim re-training opportunities.

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. 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 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. High School diploma and 2 years of experience or an equivalent combination of education and experience required. Bachelor's degree preferred. The position requires someone with desire to take initiative, excellent organizational, problem-solving skills, interpersonal skills, and the ability to thrive in a fast paced environment with competing deadlines and priorities, whether working autonomously or as part of a team. The Regulatory Affairs Specialist A must be able to exercise sound judgment and discretion in working with confidential and sensitive matters. Strong oral and written communication skills, demonstrated intermediate to advanced level PC skills including all facets of Microsoft Office, and the ability to effectively utilize the Internet are required.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$23.06 - $28.00 Hourly Rate