Regulatory Specialist A (Abramson Cancer Center)

The Perelman School of Medicine; Medicine Lake (MN); Remote; USD 40,000 - 50,000; Full time

Job summary

A distinguished educational institution is seeking a Regulatory Specialist A to support clinical research activities. The role involves administrative duties, coordinating regulatory documentation, and acting as a liaison with external partners. Ideal candidates should possess strong organizational skills, effective communication abilities, and experience in a fast-paced environment. A high school diploma with 2 years of experience is required, and a bachelor’s degree is preferred. This position offers a largely remote work environment.

Benefits

Health and Life Insurance

Tuition assistance for employees

Flexible work options

Time off for personal needs

Professional development programs

Qualifications

• Candidates must have effective communication and writing skills.
• Intermediate level of function in all Microsoft Office applications is required.
• Must exhibit strong organizational and problem-solving skills.

Responsibilities

• Act as primary liaison with external entities for regulatory documentation.
• Provide administrative support for regulatory affairs activities.
• Coordinate credentialing information for associated faculty and staff.

Skills

Effective problem solving

Critical thinking

Effective communication

Organizational skills

Time management

Ability to work in a team

Attention to detail

Education

High School diploma with 2 years of experience

Bachelor's degree preferred

Tools

Microsoft Office

Slack

Microsoft Teams

Zoom

WebEx

BlueJeans

Job description

Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Job Details

Posted Job Title: Regulatory Specialist A (Abramson Cancer Center)

Job Profile Title: Clinical Research Regulatory Specialist A

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. Contingent upon funding.

Job Description

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.

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. The 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 Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin, citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition: Take advantage of Penn\'s exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you\'ll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay