Clinical Research Coordinator B/C (Department of Otorhinolaryngology)

Clinical Research Coordinator B/C (Department of Otorhinolaryngology)

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 (Department of Otorhinolaryngology)

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 in the Department/Center. Independently manages different phases of complex clinical trials and mentors coordinators and research assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials.

Job Description

Job Responsibilities

Clinical Research Coordinator B

• Adhere to all University of Pennsylvania, GCP/ICH, and FDA guidelines, independently coordinate Phase I-IV clinical trials. Including screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation. Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures per study protocols.
• Coordinate the administration of the investigational product and study related medications including obtaining orders, collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events. Complete CRFs and data entry to study databases, sample process and shipping, patient reimbursement, research billing review, etc.
• Maintain all study-related documents. Including DOA log, source documents, CRFs, AE forms, enrollment log, training log, correspondence, etc.
• Proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies.
• Prepare and participate in the conduct of audits by the study sponsors, CROs, the FDA, and other entities as required. Conduct initiation, monitoring, and close-out visits with sponsors and/or CROs.
• Perform subject reimbursement according to study protocol and verify accuracy when applicable. Maintain records of monthly/yearly progress reports, Generate meeting agenda, Record and distribution of meeting minutes, assist with IRB, CTSRMC, or other regulatory submissions.
• Other duties and responsibilities as assigned

The Clinical Research Coordinator C will have the same duties as B but will include the following: Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinators who provide study related support (e.g., regulatory submissions and data entry). May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues. Act as back-up to the unit managers when required.

Qualifications

• CRC B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. Experience in clinical research compliance or auditing. Excellent interpersonal, writing and analytical skills. Must be detail oriented with excellent organizational and multitasking skills. The candidate should possess the ability to work independently and as part of a team. Oncology experience is preferred.
• CRC C: Bachelor's Degree and 4-5 years of experience or equivalent combination of education and experience is required. Experience in clinical research compliance or auditing. Excellent interpersonal, writing and analytical skills. Must be detail oriented with excellent organizational and multitasking skills. The candidate should possess the ability to work independently and as part of a team. Oncology experience is preferred.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$43,919.00 - $65,000.00 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. 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


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Clinical-Research-Coordinator-B-C--Department-of-Otorhinolaryngology-_JR00079475



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