Clinical Research Coordinator C (Renal-Electrolyte and Hypertension) at University of Pennsylvania in Philadelphia, Pennsylvania

Job Description:

Clinical Research Coordinator C (Renal-Electrolyte and Hypertension)





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 C (Renal-Electrolyte and Hypertension)




Job Profile Title

Clinical Research Coordinator C




Job Description Summary

This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action; will work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner. Will supervise the execution of the trial with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. S/he will provide monthly updates to the research team and the director.




Job Description



The CRC-C will coordinate clinical trials within the Renal Division's CTU, consisting of projects focused on Hypertension, Glomerular, and other Renal Diseases. The person will support the Renal Physician Investigators in clinical research ranging from observational trials to investigational drug/investigational devices, including investigator-initiated, government funded, and industry-sponsored trials. This position requires an on-site presence to interact with research subjects. Assists with the start up and initiation of new studies including development of workflow processes, source documents, and trackers. Recruits, consents, schedules, and performs study visits, enters data, resolves queries. Assigns and delegates tasks to research coordinators and research assistants. Obtain, process, and ship specimens. Candidate will be responsible for patient chart review; lab processing, EKG and other duties such as ambulatory blood pressure monitor and pulse wave velocity; perform basic laboratory assay techniques; manage inquiries related to the research studies including billing; maintain daily log books of research activity; follow strict study protocol and correspond regularly with the IRB. Train new staff members as they are added to the protocol.


Help advance the research mission of the Division and University. Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, IRB, and FDA guidelines. May require working off site and flexible hours.


Duties:


1) Participating in site initiation visits, interim monitoring visits, audits, and close-out visits. Assisting in the development/maintenance of study specific case report forms and source document tools. Developing study specific source documents and trackers. Preparing and submitting regulatory packages, including but not limited to the IRB (local and central), CAMRIS, CACTIS, radiation safety, CHP's, etc. Corresponding with sponsor & regulatory review boards. Assisting with study start up activities including investigator initiated studies.


2) Screening, recruiting, and consenting patients according to protocol. Scheduling patient study visits and any necessary testing. Conducting patient study visits according to protocol (depending on study and visit, this could include questionnaires, documenting reported medical history and side effects, collecting vitals, drawing blood, etc.). Processing and shipping study specimens including blood and urine. Monitoring and ensuring patients adherence to protocol requirements. Collecting study data, completing case report forms, and resolving data entry errors/queries


3) Communicating with study team members. Delegating and assigning tasks as necessary. Organizing and maintaining all documentation required by the Investigator, FDA, sponsor or CRO (i.e. source documents, case report forms, and research charts).


4) Participating in reoccurring study team meetings and ongoing protocol training. Training staff members as needed. Showing vigilance in patient safety, protocol compliance, and data integrity. Adhering to all University of Pennsylvania, FDA, and GCP guidelines.


5) Perform additional duties as assigned.


Bachelor's degree and 3-5 years related experience required.


*Position is contingent upon funding*




Job Location - City, State

Philadelphia, Pennsylvania




Department / School

Perelman School of Medicine




Pay Range

$50,684.00 - $77,716.00




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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