Clinical Research Coordinator A

University of Pennsylvania; United (PA); On-site; USD 47,000 - 48,000; Full time

Job summary

University of Pennsylvania's Penn Neurogenetics Therapy Center seeks a Clinical Research Coordinator A to oversee lifecycle coordination of clinical studies, from startup to closeout. You will work with the PI, study team, and Sponsor/CRO partners to ensure protocol adherence and data integrity.

Responsibilities include regulatory submissions, data collection, and participant scheduling, with flexible hours and potential weekend work.

Qualifications

• Bachelor of Science and 1–2 years experience or equivalent combination required.
• Preferred: highly motivated, detail-oriented, strong planning and multitasking abilities.
• Prior experience with industry-sponsored trials, startup activities, ethics committees and human subject research is preferred.

Responsibilities

• Reviewing and comprehending assigned protocols, study procedures and timelines to ensure compliance.
• Facilitating the approval of new study agreements and contracts.
• Assisting with development of study materials including informed consent forms and CRFs.
• Recruiting and enrolling participants, coordinating visits, and liaising with team and sponsors.
• Collecting clinical data, completing source documents, and handling samples.
• Completing electronic CRFs and responding to data clarification requests promptly.
• Maintaining study files and regulatory binders as required.
• Preparing regulatory submissions and inquiries.
• Coordinating Investigator Meetings, site visits, and monitoring visits.

Skills

Protocol review

Contract coordination

Study materials

Participant recruitment

Data collection

CRF completion

Regulatory filings

Study coordination

Mentoring

Education

Bachelor of Science

Job description

Clinical Research Coordinator A

University Overview

The University of Pennsylvania, the largest private employer inPhiladelphia, is a world-renowned leader in education, research,and innovation. This historic, Ivy League school consistently ranksamong the top 10 universities in the annual U.S. News & WorldReport survey. Penn has 12 highly-regarded schools that provideopportunities for undergraduate, graduate and continuing education,all influenced by Penn's distinctive interdisciplinary approach toscholarship and learning. As an employer Penn has been rankednationally on many occasions with the most recent award from Forbeswho named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city ofPhiladelphia. The University is situated on a beautiful urbancampus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance andlandmarks, lively cultural offerings, and wide variety ofatmospheres, Philadelphia is the perfect place to call home forwork and play.

The University offers a competitive benefits package that includesexcellent healthcare and tuition benefits for employees and theirfamilies, generous retirement benefits, a wide variety ofprofessional development opportunities, supportive work and familybenefits, a wealth of health and wellness programs and resources,and much more.

Job Description Summary

The Penn Neurogenetics Therapy Center is seeking a highly motivatedand detail-oriented Clinical Research Coordinator A (CRC A) whowill be responsible for the coordination of assignedindustry-sponsored, federally-funded and/or investigator-initiatedclinical studies through their entire lifecycle (startup, conductand closeout).

Job Description

• 1)Reviewing and comprehending assigned protocols, including studyprocedures and timelines, to ensure that clinical research andrelated activities are performed in accordance with protocol, SOP,GCP and applicable regulatory requirement,
• 2) Facilitating theapproval of new study agreements and contracts,
• 3) Assisting withthe development of study materials including but not limited to,the informed consent document, case report forms (CRFs), studylogs,
• 4) Recruiting and enrolling study participants, coordinatingstudy visits and serving as liaison between the participant, PI,members of the study team and external Sponsor/CRO teams,
• 5)Collecting clinical data, completing source documents, andcollecting, processing and shipping biological samples,
• 6)Completing electronic case report forms according to sourcedocuments and responding to data clarification requests in a timelymanner,
• 7) Establishing and maintaining study files, including butnot limited to, regulatory binders, study specific sourcedocumentation and other materials as required,
• 8) Preparing andmanaging regulatory submissions and inquiries, and
• 9) Coordinatingand attending Investigator Meetings, Site Selection visits, routinemonitoring visits, and study close out visits.
• As applicable, theCRC A will work closely with the study PI and PNTC study team toidentify problems, develop solutions, implement approved changes toprocedures and monitor results.
• As applicable, the CRC A will trainjunior members of the research team.
• Depending on study assignment,the CRC may complete research activities at the Hospital of theUniversity of Pennsylvania (primary location), PennsylvaniaHospital (PAH) and/or Children's Hospital of Philadelphia(CHOP).

The position may require communication with patients and staffoutside of office hours. Hours are flexible and may includeevenings or weekends as necessary.

The CRC A will promote institutional values of patient and visitorsatisfaction by demonstrating courtesy and respect for patients andtheir families, visitors and other employees. The CRC A willdemonstrate competence in the assessment, treatment and care ofpatients, and is expected to exhibit a professional andcompassionate demeanor in performance of responsibilities and to beunfailingly responsive to the needs of patients.

The position is contingent on continued funding.

Qualifications

• Bachelor of Science and 1 to 2 years of experience orequivalent combination of education and experience isrequired.
• Preferred: The CRC A should be highly motivated anddetail-oriented, have strong planning, organizational,multi-tasking, and prioritizing capabilities. The CRC A should possess the ability to work independently and also as part of ateam. The CRC A should have a strong ability to communicate withclinicians, researchers, sponsors, patients and families. Priorexperience with industry-sponsored trials, start-up activities(financial and regulatory), ethics committees, human subjectresearch policies and practices are preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$47,313.00 - $48,027.00 Annual Rate

Salary offers are made based on the candidate's qualifications,experience, skills, and education as they directly relate to therequirements of the position, and in alignment with salary rangesbased on external market data for the job's level. Internalorganization 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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state, or local law.

Special Requirements

Background checks may be required after a conditional job offer ismade. Consideration of the background check will be tailored to therequirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Pennoffers comprehensive medical, prescription, behavioral health,dental, vision, and life insurance benefits to protect you and yourfamily's health and welfare. You can also use flexible spendingaccounts to pay for eligible health care and dependent careexpenses with pre-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuitionbenefits. You, your spouse, and your dependent children can gettuition assistance here at Penn. Your dependent children are alsoeligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans tohelp you save for your future. Penn's Basic, Matching, andSupplemental retirement plans allow you to save for retirement on apre-tax or Roth basis. Choose from a wide variety of investmentoptions through TIAA and Vanguard.
• Time Away from Work: Penn provides you with asubstantial amount of time away from work during the course of theyear. This allows you to relax, take vacations, attend to personalaffairs, recover from illness or injury, spend time withfamily-whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with GenworthFinancial, Penn offers faculty and staff (and your eligible familymembers) long-term care insurance to help you cover some of thecosts of long-term care services received at home, in the communityor in a nursing facility. If you apply when you're newly hired, youwon't have to provide proof of good health or be subject tounderwriting requirements. Eligible family members must alwaysprovide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed tosupporting our faculty and staff as they balance the competingdemands of work and personal life. That's why we offer a widevariety of programs and resources to help you care for your health,your family, and your work-life balance.
• Professional and Personal Development: Penn provides anarray of resources to help you advance yourself personally andprofessionally.
• University Resources: As a member of the Penn community,you have access to a wide range of University resources as well ascultural and recreational activities. Take advantage of theUniversity's libraries and athletic facilities, or visit ourarboretum and art galleries. There's always something going on atPenn, whether it's a new exhibit at the Penn Museum, the latestmusic or theater presentation at the Annenberg Center, or the PennRelays at Franklin Field to name just a few examples. As a memberof the Penn community, you're right in the middle of theexcitement-and you and your family can enjoy many of theseactivities for free.
• Discounts and Special Services: From arts andentertainment to transportation and mortgages, you'll find greatdeals for University faculty and staff. Not only do Penn arts andcultural centers and museums offer free and discounted admissionand memberships to faculty and staff. You can also enjoysubstantial savings on other goods and services such as new carsfrom Ford and General Motors, cellular phone service plans, movietickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offercreative approaches for completing work while promoting balancebetween work and personal commitments. These approaches involve useof non-traditional work hours, locations, and/or jobstructures.
• Penn Home Ownership Services: Penn offers a forgivableloan for eligible employees interested in buying a home orcurrently residing in West Philadelphia, which can be used forclosing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligibleemployees on qualified expenses in connection with the legaladoption of an eligible child, such as travel or court fees, for upto two adoptions in your household.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay