Clinical Research Coordinator A

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.

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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 Coordinator A

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

This position will assist in the management of multiple clinical trials and responsibilities in Urology. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.

The day-to-day responsibilities of a CRC-A include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the study to patients and their families, consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing 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 and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, PennChart, and other study platforms; regularly reporting study progress to investigators and other managers upon request; 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.

Job Description

Job Responsibilities

· Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry

· Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines

· Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.

· Oversee study preparation and blood sample processing and analysis

· Database management and analysis

· Ordering and stocking supplies, maintaining equipment

· Educate patients and family members

· Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection

· Other duties and responsibilities as assigned

Qualifications

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

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$47,313.00 - $49,554.00 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, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .

• Special Requirements
• Background checks may be 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 ac