Clinical Research Coordinator A/B (Microbiology)

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Clinical Research Coordinator A/B (Microbiology)

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 Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Clinical Research Coordinator A/B (Microbiology)

Job Profile Title
Clinical Research Coordinator A

Job Description Summary
The Clinical Research Coordinator is responsible for oversight, execution, and regulatory compliance of human subject research carried out in the new Penn Center of Excellence for Influenza Research and Response (CEIRR). Clinical research projects will be designed to study influenza virus surveillance in the surrounding community and worldwide, as well as immune responses to both influenza virus infection and vaccination. The Clinical Research Coordinator will be recruiting patients as appropriate as outlined in research protocols, will coordinate all research visit activities for assigned projects, and will assist in the maintenance of research database in compliance with HIPAA regulations. They will also serve as the main liaison between Penn, investigators conducting clinical research activities under Penn-CEIRR, and the NIH. The scope of this job also includes coordinating the regulatory aspects of all Penn-CEIRR-funded clinical studies. The Clinical Research Coordinator will also be responsible for training new personnel who will be working on clinical activities conducted directly at Penn as well. The coordinator must be detail oriented, should have prior experience with IRB guidelines and policies and human subject research practices, and appropriate professional skills in the execution of research protocols. The Clinical Research Coordinator will generate reports documenting the progress of individual research projects for internal and external use. Position is contingent on continued funding.

Job Description

The Clinical Research Coordinator is responsible for oversight, execution, and regulatory compliance of human subject research carried out in the new Penn Center of Excellence for Influenza Research and Response (CEIRR). Clinical research projects will be designed to study influenza virus surveillance in the surrounding community and worldwide, as well as immune responses to both influenza virus infection and vaccination. The Clinical Research Coordinator will be recruiting patients as appropriate as outlined in research protocols, will coordinate all research visit activities for assigned projects, and will assist in the maintenance of research database in compliance with HIPAA regulations. They will also serve as the main liaison between Penn, investigators conducting clinical research activities under Penn-CEIRR, and the NIH. The scope of this job also includes coordinating the regulatory aspects of all Penn-CEIRR-funded clinical studies. The Clinical Research Coordinator will also be responsible for training new personnel who will be working on clinical activities conducted directly at Penn as well. The coordinator must be detail oriented, should have prior experience with IRB guidelines and policies and human subject research practices, and appropriate professional skills in the execution of research protocols. The Clinical Research Coordinator will generate reports documenting the progress of individual research projects for internal and external use. Position is contingent on continued funding.

CRC A:

- Work directly with the Center Coordinator for study start-up with limited oversight: submit Clinical Trial Agreement to institutional contracting unit for prospective clinical research projects. Attend Investigator Meetings. Host periodic monitor visits from sponsoring and monitoring companies. Host audits and inspections from oversight agencies, if applicable. Act as point-person for monitor and sponsor correspondence.

-Coordinate all clinical visit activities, interview research participants and perform assessments for assigned drug trials and other research studies. Track adverse event symptoms and medication side effects. Adhere to research protocol and timetables.

-Serve as the liaison between sub-investigators conducting clinical activities under Penn-CEIRR and the NIH. Responsible for ensuring that all essential documentation for all Penn-CEIRR clinical activities is in place, up to date, and communicated to the NIH.

-Create, submit, and obtain IRB approval for initial protocol reviews, continuing reviews, modification, deviations, etc. Responsible for IRB correspondence for assigned studies

-Relay important safety information (i.e. patient deaths, emergency admissions) to study monitoring and sponsoring organizations.

-Screen and recruit appropriate patients for prospective and ongoing clinical trials. Devise recruitment strategies and meet enrollment goals.

-Perform data entry regularly and resolve data queries. Complete, organize and file source documentation, participant files, regulatory binders and other study related materials. Ensure that records are updated and readily available to oversight agencies, (i.e. Office of Research Services, the study sponsor, FDA).
-Responsible for maintaining and adhering to CTMS calendar, assist in invoicing and tracking payments. Complete various training requirements; coordinate training and update regulatory files for the study team, including sub-investigators.

-Perform additional duties as assigned

CRC B:

In addition to the CRC A responsibilities the CRC B will work independently to consent research participants, and preparation of regulatory documents.

Qualifications
CRC A: Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. Master's Degree preferred.

Effective communication and writing skills; ability to multi-task and problem solve; Energetic, interactive and demonstrated ability to work as part of a team as well as independently; knowledge of IRB and human research protection regulations. Must possess strong computer skills and be able to independently and proficiently work in MS office suite.

CRC B: Bachelor's Degree with 2-4 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. Master's degree preferred.

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

Position is contingent upon funding.

The job pay range encompasses the full range of employees from new hires to the salaries of Penn employees with many years of experience and seniority and is not a precise indicator of salaries of new hires when looking at the top end.

Job Location - City, State
Philadelphia, PennsylvaniaClinical Research Coordinator A

Department / School
Perelman School of Medicine

Pay Range
$37,220.00 - $56,087.33
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.



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/Stemmler-Hall-Med/Clinical-Research-Coordinator-A-B--Microbiology-_JR00046051-1

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