Clinical Research Coordinator A/B (Surgery)





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 Employers By State in 2021.


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.


COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.




Posted Job Title

Clinical Research Coordinator A/B (Surgery)




Job Profile Title

Clinical Research Coordinator A




Job Description Summary

The Clinical Research Coordinator (CRC) A/B will coordinate drug and/or device clinical trials (including those under an IND/IDE) and research studies across the Dept. of Surgery as assigned. The day-to-day responsibilities of a CRC-A/B include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the trial to patients and their families [e.g., in clinic, ICU/patient rooms, and/or over the phone], consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing paper case report forms (CRFs), abstracting data from electronic health records, and conducting telephone visits per protocol; maintaining contact with/tracking study participants per protocol throughout their participation; inputting data into electronic CRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator, Abramson Cancer Center (ACC)- if applicable, FDA, and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; device/drug accountability activities in conjunction with the Investigational Drug Service at UPHS and/or device supplier; data collection and vendor oversight in the OR per institutional policies; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, PennChart, and sponsor EDC platforms; regularly reporting study progress to investigators and other managers upon request; collection (CRCs may be asked to complete phlebotomy training), storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing; organizing, maintaining, and assuring the accuracy of all study documentation including qualification materials/certifications; and preparing for and participating in study meetings and site visits (i.e., Site Selection Visits, SIVs, monitoring, and audits).


In addition to the duties outlined above, the CRC-B will be responsible for start-up activities such as assisting with budget development, establishing workflows/pathways/operationalizing protocols, and creating/leading SIVs. The CRC-B will also be expected to regularly prepare, draft, and submit regulatory correspondence (e.g., ACC-if applicable, IRB, and FDA) as appropriate. Lastly, the CRC-B will mentor/train less experienced research staff in the completion of their duties when required.


Position is contingent on continued funding.




Job Description



The Clinical Research Coordinator (CRC) A/B will coordinate drug and/or device clinical trials (including those under an IND/IDE) and research studies across the Dept. of Surgery as assigned. The day-to-day responsibilities of a CRC-A/B include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the trial to patients and their families [e.g., in clinic, ICU/patient rooms, and/or over the phone], consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing paper case report forms (CRFs), abstracting data from electronic health records, and conducting telephone visits per protocol; maintaining contact with/tracking study participants per protocol throughout their participation; inputting data into electronic CRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator, Abramson Cancer Center (ACC)- if applicable, FDA, and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; device/drug accountability activities in conjunction with the Investigational Drug Service at UPHS and/or device supplier; data collection and vendor oversight in the OR per institutional policies; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, PennChart, and sponsor EDC platforms; regularly reporting study progress to investigators and other managers upon request; collection (CRCs may be asked to complete phlebotomy training), storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing; organizing, maintaining, and assuring the accuracy of all study documentation including qualification materials/certifications; and preparing for and participating in study meetings and site visits (i.e., Site Selection Visits, SIVs, monitoring, and audits).


In addition to the duties outlined above, the CRC-B will be responsible for start-up activities such as assisting with budget development, establishing workflows/pathways/operationalizing protocols, and creating/leading SIVs. The CRC-B will also be expected to regularly prepare, draft, and submit regulatory correspondence (e.g., ACC-if applicable, IRB, and FDA) as appropriate. Lastly, the CRC-B will mentor/train less experienced research staff in the completion of their duties when required.


Position is contingent on continued funding.


Qualifications
CRC A: Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required


CRC B: Bachelor's Degree with 2-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required


Working Conditions
Office, Library, Computer Room; Requires extensive safety


Physical Effort
Typically sitting at a desk or table; Occasional lifting 25 lb. or less




Job Location - City, State

Philadelphia, Pennsylvania




Department / School

Perelman School of Medicine




Pay Range

$36,401.00 - $55,814.33




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

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  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.
  
  


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  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.
  
  


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  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.
  
  


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  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.
  
  


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  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.
  
  


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  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.
  
  


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  Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  
  


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  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.
  
  


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  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.
  
  


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  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.
  
  


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  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.
  
  


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  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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