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About the Role

The Clinical Research Coordinator B will conduct in-home and on-site study visits, distribute participant incentives, conduct literature reviews, assist in coding interviews, and prepare and process all Institutional Review Board (IRB) submissions. This role involves coordinating and maintaining study documentation, adhering to University of Pennsylvania, ICF, and FDA guidelines, preparing manuscripts for presentation, and providing administrative support for research operations. The CRC B will also manage IRB submissions and renewals, assure compliance with protocols and regulatory requirements, and promote good clinical practice.

Responsibilities

Conduct in-home and on-site study visits
Distribute participant incentives
Conduct literature reviews and synthesis
Assist in coding of interviews
Prepare and process all Institutional Review Board (IRB) submissions, amendments, continuing reviews, adverse events and serious adverse events
Coordinate, organize and maintain all documentation required by sponsor or CRO
Adhere to all University of Pennsylvania, ICF, and FDA guidelines and NIH policies
Prepare manuscripts and findings for presentation
Provide administrative support for research operations
Participate in weekly study progress meetings with the PI and research team
Manage IRB submissions and renewals in accordance with FDA and IRB guidelines
Assure compliance with the protocol and regulatory requirements
Collect, record, and maintain data and source documentations
Promote good clinical practice in the conduct of clinical investigations
Possess an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
Talk to participants to determine interest in participating in research
Verbally walk participants through consent procedures
Administer study protocol
Oversee data entry in study data set
Distribute study recruitment materials
Travel between study visits
Perform additional duties as assigned

Requirements

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required
Background checks may be required after a conditional job offer is made

Skills

In-depth knowledge of federal regulations and guidance documents for the conduct of clinical studies and human subject protection

Location

Philadelphia, Pennsylvania

Work Type

Onsite

Experience Level

2 to 3 years of experience

Education Level

Bachelor of Science

Salary/Compensations

$53,418.00 - $53,418.00 Annual Rate

Benefits

Excellent healthcare and tuition benefits for employees and their families
Generous retirement benefits
Wide variety of professional development opportunities
Supportive work and family benefits
Wealth of health and wellness programs and resources
Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
Flexible spending accounts for eligible health care and dependent care expenses
Exceptional tuition assistance for employee, spouse, and dependent children
Tuition assistance for dependent children at other institutions
Generous retirement plans (Basic, Matching, and Supplemental)
Pre-tax or Roth retirement savings options
Wide variety of investment options through TIAA and Vanguard
Substantial amount of time away from work
Long-Term Care Insurance partnership with Genworth Financial
Wellness and Work-life Resources
Professional and Personal Development resources
Access to a wide range of University resources, cultural and recreational activities
Discounts and special services for arts, entertainment, transportation, and mortgages
Flexible Work Hours
Penn Home Ownership Services (forgivable loan for eligible employees)
Adoption Assistance (reimbursement for qualified expenses)

About the Company

The University of Pennsylvania is the largest private employer in Philadelphia, 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.
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.
Philadelphia is the perfect place to call home for work and play.

Equal Opportunity

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.