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 Employers By State in 2021.
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.
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Posted Job Title
Clinical Research Coordinator
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
The CLINICAL RESEARCH COORDINATOR with Penn Dental Medicine's Center for Clinical and Translational Research team assists in the management of multiple clinical trails and responsibilities in specific area.
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. 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.
School Center Overview: Established in 1878, Penn Dental Medicine is among the oldest university affiliated dental schools in the nation. Penn Dental Medicine (PDM) is on a mission to provide the highest quality clinical and research environment for students while shaping the future of care. Join Penn Dental Medicine to live that mission every day by supporting the research and clinical needs of our patients, students, staff, and community. With PDM, not only can you maximize your career potential at an Ivy League Institution, but also you can make a real difference in the lives of our patients and students.
Job Description
Key Responsibilities:
Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data.
Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations.
Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions.
Implement approved changes to procedures as needed and monitor results.
Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.
Other duties as assigned.
Expectations:
Responsible, in collaboration with the study team, for developing/implementing recruitment strategies, assessing effectiveness of recruitment efforts, and reporting on recruitment/retention status to PI; reviewing screening process with PI including inclusion/exclusion criteria; recruiting/screening subjects for eligibility including gathering info from medical records and physician referrals; and scheduling study visits.
Schedule study visits; conduct informed consent process and ensure that the subject understands what is required; properly document the informed consent process conduct study visits, and obtain and document information within the time frame specified; write progress notes that reflect study procedures; may complete assessments on study subjects/patients per protocol; may be asked to collect biological specimens; follow-up with items and patients/subjects as part of research study.
Actively participate in study-related meetings, including but not limited to site initiation visits, weekly staff meetings, monitoring visits, and training sessions. May be asked to run study-related meetings and/or maintain complete and accurate records of all meetings and training sessions, and ensure that resulting action items are completed in a timely manner; may orient and train study staff on applicable policies and procedures and study conduct.
Demonstrate knowledge of and follow all policies and procedures of the host institution where the study is being conducted, applicable state and federal regulatory requirements, ICH GCP, Institutional Review Board (IRB) policies, HIPPA, and other requirements as appropriate; demonstrate a thorough knowledge of the research study, study rationale, study subject, and clinical procedures associated with each study to which he/she is assigned.
Interact with patients/subjects and families in a courteous and professional manner; show consistency and regular follow through with his/her patients/subjects; respond to requests in a timely manner, give complete and accurate information, and encourage required dialogue and follow- through; utilize available resources and established procedures to identify problems ideally before they happen, suggest solutions, and implement corrective action for quick resolution.
Maintain complete and accurate subject charts, case report forms, enrollment logs, and hospital record from patient screening through final follow-up; record/update/edit/maintain confidential information in a neat, accurate, and timely manner and ensure subsequent data collection as required; secure signatures and forward documents/forms to appropriate destination; maintain files in organized and up to date manner to facilitate their retrieval and maintain copies of all required documents and forms.
May be asked to serve as primary coordinator for research projects, which could include managing the day-to-day activities of the research team and ensuring that the study is conducted in the most optimal fashion.
Monitor for outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and/or Clinical Nurse; schedule, order (if appropriate), and follow-up on all tests, labs, procedures, exam, and treatment; ensure that adverse events are reported to regulatory and governing bodies in a timely manner.
Prepare and submit applications to the IRB, respond to IRB queries or concerns, and remain aware of the regulatory statuses for assigned protocols; maintain complete, accurate, and well-organized study essential documents; may be asked to draft or edit study protocols and associated documents, such as informed consent forms, manuals of procedure, advertisements, and participant brochures.
Qualifications
Bachelor's degree plus one to three years related experience or equivalent combination of education and experience. Clinical Research Coordinator (CRC) Certification must be obtained within two years from date of hire. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective verbal and written communication skills and strong analytical, organizational and interpersonal skills. Ability to work within a team environment as well as independently. Commitment to continuous learning as required by department administration. Ability to make decisions independently. Ability to manage time, multi task and prioritize work. Ability to identify, analyze and solve problems; ability to work well under pressure.
Working Conditions
Office, Library, Computer Room; Laboratory
Physical Effort
Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
School of Dental Medicine
Pay Range
$36,401.00 - $55,814.33
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.