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 (Department of Gastroenterology) Job Profile Title Clinical Research Coordinator B Job Description Summary The Clinical Research Coordinator B will play a pivotal role in managing and coordinating all phases of clinical research studies within the Division of Gastroenterology Inflammatory Bowel Disease Research Group, focusing on investigator-initiated and industry-sponsored clinical trials. This position involves collaborating with faculty investigators to design and implement study protocols, ensuring the logistical feasibility of study procedures, and overseeing the preparation and submission of regulatory documents. Key responsibilities include screening and enrolling study participants, managing study visits and treatments, coordinating the administration of investigational products, and ensuring protocol adherence and patient safety. The coordinator will also collect, review, and accurately report study data, maintain comprehensive documentation per GCP standards, and facilitate timely communication with the Principal Investigator to address study-related issues. The ideal candidate will be proactive, detail-oriented, and committed to advancing clinical research through high-quality data management and regulatory compliance. Job Description Job Responsibilities + This individual will work under general supervision + The CRC will be responsible for the coordination of a variety of 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 may also be responsible for research lab specimen processing/handling. The CRC will demonstrate vigilance in patient safety, protocol compliance, and data quality. Additional details of these responsibilities are provided below: + Collaborate closely with physicians to design, set up, and execute studies, including writing investigator-initiated IND/IDE clinical trial protocols in partnership with faculty investigators. Assist in analyzing clinical data to assess responses and outcomes, and contribute to the development of study abstracts, posters, and manuscripts. + Assist with protocol development/execution to ensure logistical feasibility of all study-related procedures and study workflow. + Participate in the development and maintenance of electronic study-specific case report forms (e.g., REDCap, CTMS) and source document tools. + Ensure preparation of all required study-related documents for submission to applicable PENN institutional committees for review and approval to start the trial (e.g., IRB, CTSRMC). + Ensure preparation of study-related documents (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic versions), and enrollment logs for study start-up. + + Be actively involved in planning and implementing patient recruitment strategies, such as reviewing medical records, discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or by phone, and asking pre-screening eligibility questions. + Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject eligibility before participation. + Manage scheduling and coordination of subject-specific treatment, follow-up visits, and procedures. + Coordinate the administration of related medications, including obtaining orders, scheduling administration dates, and monitoring subjects for post-administration adverse events or reactions. + Monitor subjects per protocol requirements and ensure adherence to the protocol. Show vigilance in patient safety, protocol compliance, and data quality. + Meet with the Principal Investigator routinely to discuss study-related issues and ensure completion of study-related procedures (e.g., determination of causality for adverse events, deviations/exceptions). + Manage the collection of data from source documents about study visits and transcribe them to case report forms, including documenting concomitant medications and adverse events. + Collect, review, and report timely, valid, and accurate study data. Obtain records required to complete case report forms and maintain clinical trial databases by completing case report forms within the sponsor-allocated time period. + Organize and maintain all documentation required by the sponsor or CRO per GCP guidelines, including source documentation, case report forms, and research records. + Ensure 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. + Coordinate investigational product ordering with IDS as needed. Ensure drug accountability and appropriate investigational product diary completion. + Perform additional duties as assigned Qualifications + Bachelor Degree and 2-3 years of experience or equivalent combination of education and experience is required. Position is contingent upon continued funding. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $43,919.00 - $54,000.00 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. ​ To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.