Clinical Research Coordinator B

University of Pennsylvania

Philadelphia (Philadelphia County)

On-site

USD 48,000 - 59,000

Full time

19 hours ago

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Benefits offered by this job

Health benefits

Tuition benefits

Retirement plans

Flexible work options

Wellness programs

Job summary

The University of Pennsylvania is seeking a Clinical Research Coordinator B in Philadelphia for the Perelman School of Medicine. This role oversees complex clinical trials from screening to data management, ensuring adherence to good clinical practice and regulatory requirements.

Responsibilities include coordinating visits, samples, regulatory documents, and budgeting, while collaborating with IRB, sponsors, and internal/external partners.

Qualifications

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Excellent verbal/written communication skills required.
Able to work collaboratively on all levels and to gain support of others.
Able to confidently interact with all levels of management including senior management, physician leaders and others.
Demonstrated complex problem solving abilities.
Strong interpersonal and multi-tasking skills.
Must be flexible, detail oriented, and organized.
Demonstrated ability to work as part of a team, as well as independently with minimal supervision.
Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 CFR, ICH Guidelines; NIH knowledge is desired.)

Responsibilities

Lead coordinator on several complex phase I-IV studies.
Coordinate protocol compliance, enrollment and retention of subjects.
Manage subject visits, study drug/devices, and regulatory submissions.
Recruit, consent, screen patients, and schedule visits.
Maintain source documents, case report forms, regulatory binders, and data entry.
Review and report study data; invoice the sponsor and manage budgets.
Attend study team meetings and regulatory trainings.
Develop and maintain study-specific regulatory documents and submissions.

Skills

Verbal and written communication

Team collaboration

Problem solving

Attention to detail

Organization

Stakeholder interaction

Education

Bachelor of Science

Job description

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.

University Overview

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

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols at the Neurology PAH Parkinson's Disease and Movement Disorders Center. The coordinator will independently manage different phases of complex clinical trials. They will coordinate the screening of patients, subject enrollment, collection and storage of biological samples, updates and maintenance of regulatory documents, and collection and management of clinical data. They will work with the IRB as well as other internal and external partners to ensure that all study documentation is submitted appropriately for initial approval and continuing maintenance.

Job Description

This position will function as lead coordinator on several complex phase I-IV studies. They will coordinate protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions. This includes recruitment, consent, and screening of patients into the protocol, scheduling subject visits, monitoring and ensuring adherence to protocol requirements, and subject training. They will maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry. They will be responsible for collecting, reviewing, and reporting study data, completing data entry, and resolving queries. They will manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples. Assessments may include ECG/EKGs, vital sign collection, cognitive testing, training subjects on study devices or programs, review of medications and medical history, review and reporting of adverse events, etc. This position will participate in study start up, ongoing study maintenance, monitoring, audits, and close out visits. They will attend study team meetings and ongoing protocol training or compliance meetings. They will develop and maintain study specific source documents, regulatory submissions, and regulatory documents/binders. They will review internal budgets, complete research billing, invoice the sponsor, and set up subject payments per budget.

Qualifications

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required
Excellent verbal/written communication skills required
Able to work collaboratively on all levels and to gain support of others
Able to confidently interact with all levels of management including senior management, physician leaders and others
Demonstrated complex problem solving abilities
Strong innovative skillsExcellent interpersonal and multi-tasking skills
Must be flexible, detail oriented, and organized
Demonstrated ability to work as part of a team, as well as independently with minimal supervision
Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired.)

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$53,418.00 - $53,418.00 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.