- S creen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants
- Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP
- Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities
- Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives
- With supervision, assist in preparation of source documents and study trackers
- will not oversee research assistants but may train the assistants on their study. Attend Investigator Meetings and communicate meeting information to the study team.
- Other duties and responsibilities as assigned
- With supervision, assist in preparation of source documents, case report forms, study trackers, protocols and consent forms, and other moderately complicated study documents
- With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
- Other duties and responsibilities as assigned
- 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 :
- Retirement:
- Time Away from Work:
- Long-Term Care Insurance:
- 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:
- University Resources:
- 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:
- Penn Home Ownership Services:
- Adoption Assistance:
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Clinical Research Coordinator A/B - Philadelphia, United States - University of Pennsylvania
Description
University OverviewThe 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.
Clinical Research Coordinator A/B
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities.
Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.
Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics.
To learn more about DOM CTU visitJob Description
Coordinator A:
Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit.
The person will support a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities.
Involvement in trials will range from consulting to serving as the primary coordinator for a study handling all coordinator activities such as:Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study team members. Recruit, consent, and screen patients according to protocol. Schedule patient visits and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocol requirements.
Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts.
Collect, review, and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, monitoring, audit, and close-out visits. Participate in study team meetings and ongoing protocol training. Assist in the development and maintenance of study specific case report forms and source document tools. Show vigilance in patient safety, protocol compliance, and data qualify. Adhere to all University of Pennsylvania, FDA, and GCP guidelines.
Coordinator B, in addition to the above, will develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start-up activities.
The CRC B will have less supervision in the management of clinical trials and will need to use more independent judgment.
Job ResponsibilitiesCoordinator A
In addition to the above job responsibilities a Coordinator B will also be responsible for the following.
Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations
Coordinator A:
Bachelor's degree required and 1-2 years of related experience (or equivalent combination of education and experience)
Coordinator B:
Bachelor's degree required and 2-4 years of related experience (or equivalent combination of education and experience)
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$37, $52,661.00 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
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.
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.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.
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.
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:
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.