Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center)

Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center)

University 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.

Posted Job Title
Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center)

Job Profile Title
Clinical Research Quality Specialist C

Job Description Summary
The Abramson Cancer Center (ACC) Department of Operations, Compliance and Monitoring (DOCM) is seeking a The Clinical Research Quality Specialist, Sr. to support our clinical research mission. The ACC clinical research portfolio comprises hundreds of studies with many being conduct across the US and in other countries. The Quality Specialist, Sr. is responsible for scheduling, coordinating and conducting monitoring and/or auditing of oncology studies across the Abramson Cancer Center which includes 12 schools, HUP, PPMC, PAH, CCG, ABBCI@LGH, PMPH, CHOP, all ACC network and affiliates as well external sites participating in ACC initiated clinical research.

NOTE: Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite multiple days a week in Philadelphia and working locally off-site. Applicants must live within a reasonable commute to downtown Philadelphia.

Visa support is not available for this position.

Job Description

Job Responsibilities

• Perform monitoring and auditing visits of all ACC studies as assigned.
• Conduct visit close-out meetings with study teams and investigators.
• Prepare formal reports of audit findings following NCI/CTEP quality and compliance standards.
• Assist with the development and implementation of corrective and preventative action plans and training related to research compliance, quality control and quality assurance to ensure compliance with federal regulations and NIH and NCI mandates.
• Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by the ACC Data and Safety Monitoring Committee.
• Strictly adhere to all ACC DOCM policies and procedures as well as have a thorough understanding of federal and local policies and guidance for the conduct of clinical research.
• Ensure data entered into case report form is accurate, complete and verifiable.
• Confirm documentation pertaining to investigational product administration and chain of custody for applicable studies.
• Confirm documentation pertaining to biospecimen collection, storage and chain of custody for applicable studies.
• Complete visit reports and follow up letters per standard operating procedures.
• Create and conduct training of investigators, sponsors and clinical research staff in areas related to clinical research.
• Provide preparation support for inspections by external bodies such as the FDA, EMA, the NCI and CTEP.
• Produced deliverables and take actions following strict deadlines for all tasks to ensure compliance with NCI requirements.
• Mentor junior compliance team staff members and work collaboratively with other DOCM functional teams.
• Perform additional duties as assigned.

Qualification

• Bachelor's degree or BSN and 5-7 years of clinical research experience with a minimum of 5 years of experience as a clinical research nurse or research coordinator and at least 3 of those years directly monitoring/auditing or preparing for and fully supporting monitoring/auditing visits of oncology trials or equivalent combination of education and experience is required. PREFERENCE WILL BE GIVEN TO RN/BSN APPLICANTS. Candidates must have an advanced working knowledge of oncology, NCTN cooperative groups, RECIST, CTCAE and NCI requirements for the conduct of research in cancer centers. Additional experience in clinical research i.e.. Data Management, Project Management, Drug Safety are a strong plus.

The appropriate candidate will possess a thorough knowledge of federal regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research. Must have a working knowledge of the operations and organization of clinical care of patients, medical records/patient charts organization and terminology, have experience navigating Electronic Medical Record systems such as Epic. Exceptional technical writing skills are essential to the success of the candidate. The candidate is expected to be detail oriented; have excellent organizational and time management skills in a very diverse setting; be able to exercise discretion in working with highly confidential and sensitive matters; must be able to work independently, multi-task and prioritize; and must be able to work under pressure while exercising mature judgment, resourcefulness and initiative.

This job is not only about your technical skills; it's about how you lend your positivity and presence, combined with your skill set to an energized environment and highly collaborative team. This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job .

Some work-related responsibilities may occur outside of regular business hours. Work requires travel between offices and entities. Position is contingent upon continued funding.

Job Location - City, State
Philadelphia, Pennsylvania
This is a hybrid eligible position with a work week divided between working onsite multiple days a week in Philadelphia and working locally off-site. Applicants must live within a reasonable commute to downtown Philadelphia. Fully remote work options are not available.

Visa support is not available for this position. Relocation is not available for this position.

Department / School
Perelman School of Medicine

Pay Range
$61,046.00 - $90,000.00 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.
  

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


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Quality-Specialist-C--Abramson-Cancer-Center-_JR00093442-1





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