University of Pennsylvania

Clinical Research Coordinator B (Regulatory Coordinator)(Department of Dermatology). Clinical Research Coordinator B. The Clinical Research Coordinator B (Regulatory Coordinator) will play a critical role in ensuring research studies comply with relevant regulations and guidelines and will recruit and screen patients for clinical trials as needed.. The CRC B (Regulatory Coordinator) will assist with preparing and processing regulatory documents through the IRB and other research review boards and have the ability to handle a variety of clinical trial related regulatory responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines.. Compliance Oversight for clinical trials; implement monitoring plans for UPenn and external study sites

clinical research coordinator

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 (Regulatory Coordinator)(Department of Dermatology) Job Profile Title Clinical Research Coordinator B Job Description Summary The Clinical Research Coordinator B (Regulatory Coordinator) will play a critical role in ensuring research studies comply with relevant regulations and guidelines and will recruit and screen patients for clinical trials as needed. They will play an essential role in the development and execution of regulatory plans for investigator and sponsor-initiated multi-site research studies and will collaborate with different research sites, such as academic centers, private practices, and research institutes, to ensure compliance with relevant regulations, Good Clinical practice (GCP), and FDA guidelines. The CRC B (Regulatory Coordinator) will assist with preparing and processing regulatory documents through the IRB and other research review boards and have the ability to handle a variety of clinical trial related regulatory responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines. The candidate should have excellent organization skills, highly effective interpersonal skills and the ability to work in a fast-paced environment with time sensitive guidelines. The candidate should be self-directed and capable of directing his or her own work with minimal to moderate supervision. Responsibilities/Duties Job Description <ul><li>Enrollment</li><li>Schedule and coordinate screening/enrollment visits</li><li>Perform screening procedures per study protocol including approaching participants in clinic or by phone, requesting and reviewing medical records, and asking eligibility questions</li><li>Complete informed consent procedures with patients during standard of care clinic visits as well as during scheduled research encounters</li><li> Recruitment:</li><li>Identify and implement strategies to ensure successful patient recruitment and enrollment goals are met within specified timelines including but not limited to development of study brochures, outreach to clinics and private providers, print and radio advertisements and internet advertisement. </li><li>Initiate and maintain communications with health care providers and staff at local health care clinics and private practices in an effort to obtain patient referrals</li><li>Triage interest inquiries (via telephone, email, or in-person encounters) and prescreen potential participants</li><li> Visit implementation/data collection:</li><li>Schedule and coordinate all study data collection visits with various Penn clinics/providers and departments for patient baseline, follow up, and end of study visits </li><li>Serve as main point of contact for study participants</li><li>Work with providers on the collection of bio-specimens and prepare samples for processing and storage</li><li>Work with providers and study participants on the completion of CRFs and source documentation for study assessments, questionnaires, and other data collection procedures</li><li> Regulatory Assistance</li><li>Assist in the development and implementation of regulatory plans for investigator and sponsor-initiated multi- site research studies (20-30 sites including academic centers, private practices, and research institutes)in accordance with University of Pennsylvania, GCP, and FDA guidelines </li><li>Assist in the development and maintenance of study specific case report forms and source document tools</li><li>Assist with the development and maintenance of standard operating procedures and Manual of Procedures</li><li> Regulatory Preparation</li><li>Participate in post-award communications with study sponsor. Complete all sponsor documentation and reporting requirements. </li><li>Prepare and process all required regulatory documents through the IRB and other research review boards- including new submissions, consent form revisions, continuing reviews, amendments, reportable events and adverse event, as well as organize and maintain all essential documents in study regulatory files</li><li> Regulatory Compliance</li><li>Compliance Oversight for clinical trials; implement monitoring plans for UPenn and external study sites </li><li>Maintain a current knowledge of relevant regulations and update documentation in order to ensure compliance</li><li>Work with research teams to prepare for audits including reviewing regulatory binders and performing internal audit and other internal QA activities</li><li> Other responsibilities:</li><li>Participate in research team meetings, and ongoing protocol training and compliance meetings</li><li>Support and interact with PIs, co-investigator, research managers, and other CRCs and staff</li><li>Maintain all relevant trainings and certifications (CITI, GCP, PENN CRC certificate and assigned Penn Profiler trainings) </li><li>Adhere to all University of Pennsylvania, GCP, and FDA guidelines</li><li>Position involves work-related responsibilities that may occur outside of usual 8:30am-5:00pm workday</li><li>Perform additional duties as assigned. </li></ul>Qualifications <ul><li>Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.</li><li>Cover letter required. </li></ul>Target Salary: up to $56,349/annual This position is contingent upon funding. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $43,919.00 - $56,349.00 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 <ul><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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. </li></ul>To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

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