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Clinical Research Coordinator A/B (Division of Urology/Department of Surgery)

University of Pennsylvania

Philadelphia (Philadelphia County)

On-site

USD 43,000 - 55,000

Full time

30+ days ago

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Job summary

An established industry player seeks a Clinical Research Coordinator to manage clinical trials in the Division of Urology. This role involves patient recruitment, data management, and ensuring compliance with regulatory standards. The ideal candidate will work closely with the Principal Investigator and study team to facilitate smooth operations of clinical studies. Offering a vibrant urban campus and a supportive work environment, this position is perfect for those looking to make a significant impact in clinical research while enjoying the rich cultural offerings of Philadelphia. Join a team dedicated to innovation and excellence in healthcare research.

Benefits

Comprehensive Medical Benefits

Tuition Assistance

Generous Retirement Plans

Flexible Work Hours

Professional Development Opportunities

Health and Wellness Programs

Discounts on Goods and Services

Long-Term Care Insurance

Adoption Assistance

Time Away from Work

Qualifications

Bachelor's degree with 1-3 years of relevant experience required.
Strong skills in data management and regulatory compliance.

Responsibilities

Coordinate clinical studies, including recruitment and data entry.
Ensure compliance with protocols and regulatory requirements.
Maintain study documentation and oversee sample processing.

Skills

Clinical Research Coordination

Data Entry

Patient Recruitment

Regulatory Compliance

Database Management

Education

Bachelor of Science

Tools

Electronic Data Capture (EDC) Systems

PennCTMS

PennChart

Clinical Research Coordinator A/B (Division of Urology/Department of 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 naming 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 a 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 Title
Clinical Research Coordinator A/B (Division of Urology/Department of Surgery)

Job Profile Title
Clinical Research Coordinator A

Job Description Summary
This position will assist in the management of multiple clinical trials and responsibilities in the Division of Urology. The Clinical Research Coordinator A/B will be responsible for data entry, organizing, maintaining, and assuring the accuracy of all study documentation for the site-specific protocols. 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.

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

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 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.

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, IRB, and FDA) as appropriate. Lastly, the CRC-B will mentor/train less experienced research staff in the completion of their duties when required.

The CRC-A/B will have the responsibilities described above working with minimal to no staff supervision. Position is contingent on continued funding.

Job Responsibilities

Coordinate and conduct clinical studies, including 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, including 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, including possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection.

Position is contingent upon continued grant funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman 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

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 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.
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, but 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.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve the use of non-traditional work hours, locations, and/or job structures.
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.
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.