Clinical Researcher Coordinator B/C

University of Pennsylvania; Pennsylvania; On-site; USD 53,000 - 63,000; Full time

Benefits offered by this job

Health benefits

Tuition benefits

Retirement plans

Wellness programs

Flexible work hours

Job summary

The University of Pennsylvania seeks a Clinical Researcher Coordinator B/C to support infectious disease studies, including HIV and gene-therapy trials. The role requires on-site presence, participant interaction, and coordination with investigators, regulatory boards, and sponsors.

Responsibilities include protocol development, regulatory submissions, patient recruitment, study visits, data management, and adherence to GCP guidelines.

Qualifications

• Strong problem-solving and writing skills.
• Excellent communication and organizational abilities.
• Knowledge of IRB/human research protection regulations.

Responsibilities

• Screen, recruit, and enroll consenting patients per Good Clinical Practice guidelines.
• Coordinate trials within Penn Infectious Disease Clinical Trials Unit (HIV and other infectious diseases).
• Prepare study documents, communicate with study teams and regulatory boards, and manage data and regulatory files.
• Lead development of complex protocols/consents for gene therapy workflows and monitor study progress.

Skills

Problem-solving

Communication

Organization

Time management

Attention to detail

Teamwork

Independent work

IRB knowledge

Phlebotomy (preferred)

Education

Bachelor's degree

Job description

Clinical Researcher Coordinator B/C

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 to scholarship 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, andrecreational 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.

Posted Job Title

Clinical Researcher Coordinator B/C

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

As part of the Infectious Disease Clinical Trials Group, this position will coordinate clinical research consisting of projects in HIV and other infectious diseases. The person will support Infectious Disease Investigators in clinical research ranging from observational trials to investigational product trials, including both investigator-initiated and industry-initiated trials. Prior experience in gene therapy clinical trials is ideal but not required. Work requires on-site presence and interaction with research subjects. Research coordinator work includes study implementation, document development, submission to regulatory boards, subject recruitment and enrollment, study visits, and regulatory compliance in one or more studies.

Job Description

Job Responsibilities

Screen, recruit, and enroll consenting patients using Good ClinicalPractice guidelines and conduct compliance monitoring of studyparticipants across infectious disease and gene therapyprotocols.

Coordinator B: Participate in and coordinate clinical trials withinthe Penn Division of Infectious Disease Clinical Trials Unit,consisting of projects in HIV and other Infectious Diseases. Theperson will support Infectious Disease Investigators in clinical research ranging from observational trials toinvestigational product trials, including bothinvestigator-initiated and industry-initiated trials. Work requireson-site presence and interaction with research subjects. Coordinator duties include:

Assist in development of study documents. Communicate with studyteam members and regulatory review boards. Recruit, consent, and screen patients according to protocol (including specialized genetherapy protocols). Schedule patient visits and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocolrequirements. Organize and maintain all documentation required by the Investigator, sponsor, or CRO, including source documentation, case report forms, and research charts. Collect, review, and report study data. Complete case report formsand resolve data queries. Process and ship study specimensincluding blood and urine. Participate in initiation, monitoring,audit, and close-out visits. Participate in study team meetings andongoing protocol training. Assist in the development/maintenance ofstudy-specific case report forms and source document tools. Showvigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA, and GCPguidelines.

Coordinator C: The Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from theprogram manager. In addition, will develop complex documents suchas protocols and consents (specifically incorporating gene therapy workflows and endpoints), lead teammeetings, and may take a lead role in study communication withinternal and external groups. Work directly with investigators todesign, set-up, and execute studies. Accountable for making sure study timelines and goals are met. Independently move a clinical trial through each phase ofdevelopment, resolving issues and queries with input from asupervisor as required. Management of clinical trials with a higherdegree of independent judgment.

Conduct study-related visits, including procedures such as blooddraws, vitals, medical history, ECGs, specialized gene therapyprotocol administration/monitoring, and processing of biologicalspecimens; manage study data and regulatory files per GCP.

Prepare for audits, review regulatory binders, perform internalaudit and other QA activities, and handle monitor/audit visits withCROs, the FDA, and other entities.

Correspond regularly with the Institutional Review Board and other regulatory agencies (including IBC/gene therapy oversight bodies asapplicable), including preparation and submission of protocols,protocol amendments, SAE reports, and DSMB subjectnarratives.

Coordinator B: With supervision, assist in preparation of researchprotocols and documents.

Coordinator C: Work with primary investigators to developinvestigator-initiated protocols, case report forms, and databases. Independently design research documents including consent forms,source documents, CRFs, and training SOPs for complex trials(including gene therapy).

Coordinator B: With the help of the program manager,manage/coordinate/organize the daily work of research assistantsfor tasks such as recruitment, study visits, and regulatory, andtrain them in these tasks. Attend Investigator Meetings andcommunicate meeting information to the study team.

Coordinator C: A CRC C will be expected to do thisindependently.

Perform additional duties as assigned.

Position contingent on funding.

Qualifications

Effective problem-solving abilities; effective communication andwriting skills; strong organizational and time management skills;flexible and able to multi-task; strong attention to detail;demonstrated ability to work as part of a team, as well asindependently; knowledge of IRB and human research protectionregulations; highly reliable and good work ethic required. Recentexperience with phlebotomy preferred.

• Coordinator B: Bachelor's degree required and 2-4 years ofrelated clinical research experience (or equivalent combination ofeducation and experience).
• Coordinator C: Bachelor's degree required and 4+ years of relatedclinical research experience (or equivalent combination ofeducation and experience)

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$53,418.00 - $63,085.00 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 yourfuture. 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