Clinical Research Coordinator A
Company: University of Pennsylvania
Location: Philadelphia
Posted on: April 25, 2025
Job Description:
Clinical Research Coordinator A
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 A
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
The Cardiovascular Clinical Research Unit (CCRU) Team seeks a
full-time Clinical Research Coordinator to assist in the
organization, coordination and implementation of clinical research
studies involving a wide variety of investigational products and
various sponsors. This position will report directly to the
Associate Director, Clinical Research Operations and work directly
with PIs on clinical research performed. He/she will be responsible
for supporting the following aspects of clinical trial coordination
including subject recruitment, detailed data entry, subject visits,
and follow-up and regulatory documentation. The successful
candidate will comply with all policies relating to the University
of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory
standards.
The Clinical Research Coordinator (CRC) is an integral and
essential member of the CCRU. We are looking for an enthusiastic,
professional and committed team member to work closely with our
clinical research investigators, research managers and regulatory
personnel.
Career Development Opportunities
The CCRU is focused on career development of CRCs and offers an
advanced infrastructure of leadership and training to guide and
support new CRCs from initial training, to continued professional
growth.
Job Description
This position is contingent upon favorable funding.
This individual will work under general supervision
The CRC will assist in the coordination of complex clinical
research protocols, including 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 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. Additional details of these responsibilities are
provided below:
- Coordinate the conduct of Phase I-IV investigator initiated and
sponsored clinical research studies.
- Complete relevant training to function in the role including
but not limited to electronic databases, and processing/shipping
specimens. Coordinate completion and appropriate documentation of
new study staff training during any staffing transitions or for
coverage purposes.
- Organize, participate and assist in the preparation of
documents needed for initiation, monitoring, internal and external
auditing, and study close-out visits. Interface with regulatory
authorities, Sponsors and cooperative groups as directed by the
CCRU program managers and associate directors.
- May participate in the clinic to explain a trial and conduct
informed consent with the patient and family.
- Schedule and oversee participant visits and any necessary
testing and appointment coverage according to protocol and in
accordance with Good Clinical Practice (GCP) (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).
- Monitor subjects per protocol requirements and ensure adherence
to protocol. Show vigilance in patient safety, protocol compliance
and data quality.
- Communicate clinical trial patient activity to the
investigational drug pharmacy (IDS) to ensure adequate drug supply.
Ensure drug accountability and appropriate investigational agent
diary completion.
- Participate in the maintenance of electronic study specific
case report forms (i.e. REDCap, CRMS etc.) and source document
tools. Organize and maintain all documentation required by the
sponsor or CRO per GCP - includes source documentation, case report
forms, and research charts.
- Collect, review and report timely, valid, accurate study data.
Obtain records required to complete case report forms.
Update/maintain study record in the Clinical Research Management
System (CRMS) in real-time. Maintain clinical trial databases by
completing case report forms typically within 5 business days of
subject visits and resolving data queries within 10 days of
issuance. These timelines may be shortened during periods of data
lock or in preparation for abstract/manuscript submission.
Responsible for IND/IDE reporting and/or assisting Sponsor with
annual IND/IDE reporting. Job Responsibilities
- Identify and Recruit Study Subjects.
- Organize and Coordinate Study Procedures.
- Data Entry and Database Management.
- Sample Processing.
- Other duties and responsibilities as assigned Qualifications
- Bachelor of Science and 1 to 2 years of experience or
equivalent combination of education and experience is required. Job
Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$46,500.00 - $50,000.00 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.
---
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/Smilow-Center-for-Translational/Clinical-Research-Coordinator-A_JR00104873
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