Clinical Research Coordinator B/C - Epidemiology Division

Clinical Research Coordinator B/C - Epidemiology Division

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.

Posted Job Title
Clinical Research Coordinator B/C - Epidemiology Division

Job Profile Title
Clinical Research Coordinator B

Job Description Summary
The Clinical Research Coordinator B/C will assist in the coordination and management of multiple clinical trials along with other research projects and responsibilities in the Infectious Diseases C-STAR Research Team and MOTION Laboratory Group.

Duties include, but not limited to, the following: screening, recruiting, consenting and enrolling eligible subjects per protocol using GCP guidelines. Scheduling clinical and research visits, interacting with clinicians and staff to schedule and oversee research testing, assist or coordinate specimen collection (including coordinating serum collections from clinical labs) and transport/shipment of specimen samples, preparing trials for audits and inspections. The CRC will participate in study team meetings and ongoing protocol training/compliance meetings and will be expected to adhere to all University of Pennsylvania, FDA, and GCP guidelines.

The CRC-B/C will be responsible for accurate data collection and overseeing the quality of the clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training. The CRC B/C is also responsible for research lab specimen processing/handling. The CRC will demonstrate vigilance in patient safety, protocol compliance, and data quality, and will participate in data organization for research publications, with potential for co-authorship. Study enrollment/activities may occasionally require driving/traveling to other sites located offsite from University of Pennsylvania's Main Campus. This position requires flexibility to work occasional nights/weekends.

Clinical Research Coordinator C (CRC-C): In addition to performing all duties above, the CRC-C is expected to run projects independently, with minimal supervision. May act in a lead capacity or as back-up to the supervisor. CRC-C is expected to draft complex documents including protocols, and Manual of Procedure (MOP).

Job Description

Job Responsibilities

• Coordinate and conduct clinical trials. Promote good clinical practice in the conduct of clinical trials. Demonstrate knowledge of the federal regulations for the conduct of clinical studies and human subject protection.
• Act in lead capacity in coordination and conduct of clinical trials and other projects and assist Research Team Managers in overseeing execution of project timelines as well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits.
• Assure compliance with the protocol and regulatory requirements includes collecting, recording, and maintaining data and source documentations. This involves organizing, participating and assisting in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
• Interface with regulatory authorities (OCR at Penn), Sponsors and any cooperative groups.
• Coordinate and conduct all activities around the clinical trials, including: subject recruitment, informed consent, chart maintenance and data entry; being actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and follow-up patient visits and discussing with investigators, reaching out to treating physicians, approaching potential subjects, determining if subjects meet pre-screening eligibility requirements, etc.). Explain trial and conduct informed consent with the patient and family in detail, educating patients and family members as well as monitoring subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. This includes completing relevant trainings to function in the role including but not limited to electronic databases, and processing/shipping specimens (REDCap, CRMS, PennChart, LabVantage). May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues. Coordinate completion and appropriate documentation of study staff training.
• Schedule and oversee subject visits and any necessary testing and specimen collection needed according to protocol and in accordance with Good Clinical Practice, detailed documentation of study activities (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities). This involves communicating and coordinating all aspects of dealing with and handling the investigational product with the manufacturing/research lab, according to protocol. Oversee study preparation and sample processing, transport and analysis.
• Database management and analysis. This involves collection, review and reporting timely, valid, accurate study data; obtaining records required to complete case report forms; updating/maintaining study record in the Clinical Research Management System (CRMS) in real-time. This duty also includes maintaining clinical trial databases by completing case report forms in a timely manner (i.e. REDCap, CRMS etc.) and source document tools (PennChart); organizing and maintaining all documentation required: source documentation, case report forms, and research charts.
• Participate in weekly meetings to provide enrollment updates, to review the status of ongoing patients; discuss updates/issues with the Research Team's Program Manager and prepare updates/meeting minutes. Work as a part of the research team to maximize the efficiency and quality of research performed.
• Other duties and responsibilities as assigned such as: inventorying supplies, maintaining equipment; performing study enrollment/activities that may occasionally require driving/traveling to other sites located offsite from University of Pennsylvania's Main Campus.

*Position contingent upon continued funding*

Qualifications

The CRC-B/C ideally will have prior experience working with epidemiological studies within all aspects of infectious diseases.

Clinical Research Coordinator B: Bachelor's Degree with 2-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required.

Clinical Research Coordinator C: Bachelor's degree and 4-6 years of related experience, or equivalent combination of education and experience, are required.

Additionally, the CRC B/C will have the following:
(1) practical experience coordinating the day-to-day activities of multiple research protocols
(2) effective verbal and written communication skills
(3) ability to learn new methods quickly and multi-task
(4) demonstrate the ability to work as part of a team as well as independently
(5) knowledge or experience in clinical trials preferred but not required
(6) ability to work flexible hours
(7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines

This position requires flexibility to work occasional nights/weekends.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$52,500.00 - $62,000.00 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, 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 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. 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 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.

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


Equal Employment 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.
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Blockley-Hall---9th-Floor/Clinical-Research-Coordinator-B-C---Epidemiology-Division_JR00106356-1









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