Clinical Research Coordinator A/B (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 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.
COVID-19 vaccination or a University authorized exemption is a requirement for all positions at the University of Pennsylvania. For more information about Penn’s vaccine requirements, visit the Penn COVID-19 Response website for the latest information.
Posted Job Title
Clinical Research Coordinator A/B (Renal – Electrolyte and Hypertension)
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
The Renal-Electrolyte and Hypertension Division in the Department of Medicine supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated trials. Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. With variations outlined below, this position is responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal-Electrolyte and Hypertension Division. The position involves working directly with study physicians, research nurses, and other research staff at Penn and at other sites. This position will recruit and perform study visits, enter data, resolve queries, obtain, process, and ship specimens. The position will help advance the research mission of the Division and University and show vigilance in patient safety, protocol compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require working off site and flexible hours.
Assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Assist with creation of master trial file and obtain the appropriate signatures for the regulatory forms. The candidate must have the ability to multi-task and be flexible. Should have excellent interpersonal skills and be able to work as part of several teams. Must be able to direct his or her own work and is able to work independently.
Job Description
Clinical Research Coordinator A:
Duties:
1) Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
2) Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
4) Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
5) With supervision, assist in preparation of source documents and study trackers
6) CRC A will not oversee research assistants but may train the assistants on their study. Attend Investigator Meetings and communicate meeting information to the study team.
7) Perform additional duties as assigned.
Qualifications: Bachelor’s Degree with 1-2 years of related experience
Clinical Research Coordinator B:
Duties:
1) Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
2) Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
4) Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
5) With supervision, assist in preparation of source documents, case report forms, study trackers, protocols and consent forms, and other moderately complicated study documents
6) With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
7) Perform additional duties as assigned.
Qualifications:
CRC-A: Bachelor’s Degree with 1-2 years of related experience or equivalent combination of education and experience required
CRC-B: Bachelor’s Degree with 2-3 years of related experience or equivalent combination of education and experience required
Job Location – City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$37,220.00 – $56,087.33
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
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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