Clinical Research Coordinator A

The University of Pennsylvania is a world-renowned leader in education, research, and innovation. They are seeking a Clinical Research Coordinator A to coordinate investigator-initiated studies and multi-center research studies, ensuring patient safety and protocol compliance.

Responsibilities

• Screen, 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, processing and shipping 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
• Ordering and stocking supplies, maintaining equipment
• With supervision, assist in preparation of research protocols and 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
• Perform additional duties as assigned

Preferred

• prior experience in gene therapy trials
• Gene Therapy Trials Experience

Benefits

• 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.
• 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.
• 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.
• Penn provides you with a substantial amount of time away from work during the course of the year.
• 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.
• 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.
• Penn provides an array of resources to help you advance yourself personally and professionally.
• 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.
• 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 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 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.

Company

• Ivy League university offering undergraduate and graduate education
• Philadelphia, Pennsylvania, USA
• http://www.upenn.edu/
• Founded in 1740
• 10001+ employees

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination education and experience is required
• 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
• 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
• Prior experience in gene therapy trials
• Bachelor of Science and 1 to 2 years of experience or equivalent combination education and experience is required.

Required skills

• Biological specimen processing and shipping, Blood draws, Clinical Practice (GCP) guidelines, Clinical data management, Clinical research protocols, Clinical trial coordination, Electrocardiograms (ECGs), FDA guidelines, Gene therapy trials, IRB regulations, Internal auditing, Medical history collection, Patient recruitment and enrollment, Quality assurance (QA) activities, Regulatory binder preparation, Regulatory compliance, Vital signs measurement

Preferred skills

• prior experience in gene therapy trials

Experience

• 1-2 years