Clinical Research Coordinator B/C

University of Pennsylvania•Philadelphia, PA

20h

About The Position

The clinical research coordinator B/C will manage the coordination of Phase I-IV multi-center clinical trials, including coordination, organization and maintenance of all documentation required by Sponsor or CRO as well as working with partnering institutions on creating multi-center budgets, managing invoicing, and IRB paperwork under limited supervision and will need to use independent judgment; resolve data queries with Sponsor or CRO; recruit, screen and enroll potential study subjects; participate in the conduct of audits; process and ship blood and specimens; schedule patient visits and any necessary testing; obtain records required to complete case report forms; conduct initiation, monitoring and close out visits with Sponsor of CRO; adhere to all PENN, ICF, and FDA guidelines; prepare and process all IRB documentation. The clinical research coordinator B will also manage clinical trials that involve hands-on, technologically advanced and special skill set involving investigational procedures with Radiology.

Requirements

Clinical Research Coordinator B Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Clinical Research Coordinator C Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

Nice To Haves

CRC-B practical experience coordinating the day-to-day activities of multiple research projects; effective verbal and written communication skills; ability to learn new methods quickly and multi-task; demonstrated ability to work as part of a team as well as independently; knowledge or experience in cancer preferred but not required; ability to work flexible hours.
Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
CRC-C practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; effective verbal and written communication skills; ability to learn new methods quickly and multi-task; demonstrated ability to work as part of a team as well as independently; knowledge or experience in cancer preferred but not required; ability to work flexible hours; possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines

Responsibilities

Coordinate Phase I – IV clinical trials.
Coordinate, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., source documentation, case report forms, study and regulatory binders, and patient binders).
Resolve data queries with sponsor and CROs
Recruit, screen and enroll potential study patients as specified per protocol.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required.
Process and ship blood, urine, and serum specimens for each trial.
Schedule patient visits and any necessary testing; within the EMR or other tools
Attend Investigator Initiation meetings
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.
Obtain records required to complete case report forms
Maintain source documentation
Participant/ subject appreciation and recognition
Ability to communicate and build a rapport with subjects
Conduct initiation, monitoring, and closeout visits with sponsors and/or CROs
Show vigilance in patient safety, protocol compliance, and data quality
Adhere to all University of Pennsylvania, ICF, and FDA guidelines
Coordination and oversight on time to study start up
Provide feedback and critical analysis of clinical research protocols
Participate in CRF testing and potentially design
Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and CROs
Obtain the appropriate signatures for regulatory forms.
Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance).
Resolve regulatory related queries with IRB, study sponsors and CROs
Develop complex documents such as protocols and consents
May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues
Act in lead capacity in coordination of research team projects and assist Associate Director in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support (e.g., regulatory submissions and data entry)
Act in a lead for study communication with internal and external groups
Work directly with investigators to design, set-up and execute studies
Accountable for ensuring study timelines and goals are met.
May participate in and support budget preparation for trials as needed.
May support a clinical trial budget through each phase of development, resolving issues and queries with input from the Research Team’s PM/PI as required
Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required
Management of clinical trials and will need to use more independent judgment

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. 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.
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.