Clinical Research Coordinator A/B (Department of Cardiovascular Surgery) at University of Pennsylvania in Philadelphia, Pennsylvania

Job Description:

University OverviewThe 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 TitleClinical Research Coordinator A/B (Department of Cardiovascular Surgery)

Job Profile TitleClinical Research Coordinator A

Job Description SummaryCRC A: The clinical research coordinator will be responsible for data entry, organizing, maintaining, and assuring the accuracy of all study documentation. The coordinator will oversee 2 or more clinical trial ensuring that the integrity of the protocol is maintained, all data and queries are answered in a timely manner, appropriate AEs and SAEs are reported to the sponsor and IRB per protocol. The CRC will participate in clinic to explain the trial to the patient and family, enroll and consent patients and complete any follow-up or research activity required. All communication with the participant or on behalf of the participant must be documented in PennChart. The CRC will be responsible for gather the data per the protocol and bring any adverse events to the attention of the PI or any other part of the research team that the PI delegates the task. The CRC will work closely with the administrative assistant to ensure that study visits are scheduled along with the appropriate studies according to the protocol. The CRC will conduct phone interviews if necessary. The CRC must complete relevant training to function in the role including electronic databases, processing and shipping specimens and phlebotomy. The CRC will maintain all mandatory trainings required to oversee and manage the trials which they are the lead CRC or backup CRC. The CRC will report directly to the Project Manager or the program Supervisor. The CRC must be sufficiently knowledgeable about Microsoft word, Excel, and other standard programs. The CRC must maintain professionalism and follow the guidelines of the institution.


CRC B: The CRC B will have all of the same responsibilities as a CRC A with added responsibilities and better knowledge base of clinical research. A CRC B is expected to manage 5 or more clinical trials. The CRC B will be well versed in Good Clinical Practice. The CRC B will have experience in managing all aspects of a trial including trial start-up, creating consents, IRB submissions, recruitment, enrollment, AE management, investigational and drug management, data entry, resolution of queries, strategies to maintain compliance and closeout of a trial. The CRC B will be able to effectively manage multiple trials and assist in aspects of other trials. The CRC B will demonstrate leadership skills within the program and be able to identify common challenges and brain-storm creative ideas to problem-solve issues.
The CRC will update the PI and Subs of all protocol modifications, AEs, SAEs and deviations related to the protocol. The CRC will document education and notification of protocol related information. The CRC B will educate subjects and the family of potential participates in the trial which includes the device/drug, procedure and follow up to ensure informed consent is obtained. All interaction must be documented in PennChart. In the event a subject is unable to return for their study visit the CRC will contact the subject and investigate the barriers and problem-solve possible solutions.
The CRC must be sufficiently knowledgeable about Microsoft word, Excel, and other standard programs. The CRC must maintain professionalism and follow the guidelines of the institution.


This position is contingent upon continued grant funding.


Qualifications:
CRC A: Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
CRC B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Job Description

CRC A: The clinical research coordinator will be responsible for data entry, organizing, maintaining, and assuring the accuracy of all study documentation. The coordinator will oversee 2 or more clinical trial ensuring that the integrity of the protocol is maintained, all data and queries are answered in a timely manner, appropriate AEs and SAEs are reported to the sponsor and IRB per protocol. The CRC will participate in clinic to explain the trial to the patient and family, enroll and consent patients and complete any follow-up or research activity required. All communication with the participant or on behalf of the participant must be documented in PennChart. The CRC will be responsible for gather the data per the protocol and bring any adverse events to the attention of the PI or any other part of the research team that the PI delegates the task. The CRC will work closely with the administrative assistant to ensure that study visits are scheduled along with the appropriate studies according to the protocol. The CRC will conduct phone interviews if necessary. The CRC must complete relevant training to function in the role including electronic databases, processing and shipping specimens and phlebotomy. The CRC will maintain all mandatory trainings required to oversee and manage the trials which they are the lead CRC or backup CRC. The CRC will report directly to the Project Manager or the program Supervisor. The CRC must be sufficiently knowledgeable about Microsoft word, Excel, and other standard programs. The CRC must maintain professionalism and follow the guidelines of the institution.

CRC B: The CRC B will have all of the same responsibilities as a CRC A with added responsibilities and better knowledge base of clinical research. A CRC B is expected to manage 5 or more clinical trials. The CRC B will be well versed in Good Clinical Practice. The CRC B will have experience in managing all aspects of a trial including trial start-up, creating consents, IRB submissions, recruitment, enrollment, AE management, investigational and drug management, data entry, resolution of queries, strategies to maintain compliance and closeout of a trial. The CRC B will be able to effectively manage multiple trials and assist in aspects of other trials. The CRC B will demonstrate leadership skills within the program and be able to identify common challenges and brain-storm creative ideas to problem-solve issues.

The CRC will update the PI and Subs of all protocol modifications, AEs, SAEs and deviations related to the protocol. The CRC will document education and notification of protocol related information. The CRC B will educate subjects and the family of potential participates in the trial which includes the device/drug, procedure and follow up to ensure informed consent is obtained. All interaction must be documented in PennChart. In the event a subject is unable to return for their study visit the CRC will contact the subject and investigate the barriers and problem-solve possible solutions.

The CRC must be sufficiently knowledgeable about Microsoft word, Excel, and other standard programs. The CRC must maintain professionalism and follow the guidelines of the institution.

This position is contingent upon continued grant funding.

Qualifications:

CRC A: Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

CRC B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Job Location - City, StatePhiladelphia, Pennsylvania

Department / SchoolPerelman School of Medicine

Pay Range$43,888.00 - $55,000.00 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

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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.

  
  

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

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