Clinical Research Quality Specialist C (Office of Clinical Research)

Description

The CR Quality Specialist C is responsible for performing GCP compliance activities for sponsored IND clinical research trials and Investigator initiated trials to verify human subjects are safe, the data accurate, complete and verifiable from source documents.

The Clinical Research Quality Specialist must verify the site is conducting the trial in compliance with the approved protocol.

Duties :

• The Quality Specialist is to ensure the rights, safety, and welfare of all subjects are protected.
• The monitor is to confirm all clinical trial data is accurate, complete, and verifiable from the source documents, and the clinical trial data has been collected based on ALCOA standards.
• The Quality Specialist is to verify the trial is being conducted in compliance with the current approved study documents, ICH GCP, and with the applicable regulatory requirements.
• The Quality Specialist is to confirm documentation pertaining to investigational product and / or investigational device administration and the chain of custody is maintained.
• The Quality Specialist is to review initial and follow up of all SAEs, Medwatches, and AEs to ensure subject safety.
• The Quality Specialist is to ensure the site subject binders and regulatory files are complete and up to date.
• The Quality Specialist is to complete visit reports and follow up per SOP guidelines.
• The Quality Specialist is to work with site during review to ensure training completed.
• The Quality Specialist will train both site and sponsor staff when training issues are identified.

Qualifications :

• Bachelor’s Degree Required, Master’s degree preferred
• 5-7 years of relevant experience or equivalent combination of education and experience in clinical / translational research compliance and / or operations in any of the following areas : academia, pharmaceutical, contract research organization (academic or private sector), or site management organization (academic or private)
• Direct experience in the following areas preferred : compliance and oversight for clinical trials monitoring or auditing, advanced knowledge of regulations governing human research
• Knowledge of regulations governing human research including ICH Good Clinical Practice Guidelines
• Ability to respect and protect highly sensitive and confidential information

Resume and cover letter required with application

Targeted Pay Range : $82,243- $88,000

This Targeted Pay Range is only applicable to this job posting. All salary 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.

Job Location - City, State

Philadelphia, Pennsylvania

Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely

Department / School

Perelman School of Medicine

Pay Range

$61,046.00 - $88,000.00 Annual Rate

Salary 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

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.