Clinical Research Coordinator B/C

The University of Pennsylvania, a prestigious Ivy League institution, is seeking a Clinical Research Coordinator B/C to manage clinical trials in the department of Radiation Oncology. This role involves coordinating trial activities, ensuring regulatory compliance, and supporting patient enrollment and data collection.

Responsibilities

Coordinate trial related activities to ensure the execution of the trials adheres to the protocol and regulatory compliance; maintaining regulatory documents per sponsor requirements, University of Pennsylvania, FDA, and GCP standards and guidelines; preparing and participating study monitoring and audit visits

Communicate with potential patients, pre-screening, scheduling, consenting, and enrolling patients; ensuring all the enrolled subjects have documented eligibility check list and signed appropriate version of consent

Coordinate research visits; maintaining source documentation, data collection and completing CRFs; obtaining, handling, processing, transferring /shipping of biospecimens when applicable

Track AE/SAE, maintaining documentation, and study logs; coordinating with regulatory specialist when regulatory entities report is needed, such as reportable AE/SAE deviations

Conduct follow up phone calls to participants; includes tracking participants through the timepoints, uploading data to relevant databases; perform data QC and address queries

Perform research billing review, subject reimbursement when applicable; documenting all trainings and essential correspondence that related to study

Attending study related meetings and other meetings as required, maintaining/ordering study materials as needed

Adhere to all University of Pennsylvania, ICF, and FDA guidelines

In addition to the above, the CRC C will will work with minimal supervision from their project manager and independently manage their assigned clinical trials

The CRC-C may act in a lead capacity in coordination with CRU Research Team projects and assist Research Team Managers in overseeing the execution of project timelines as well as completion of study related activities delegated to the research coordinators(A/B) who provide study related support

May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues

Preferred

Regulatory experience is preferred

Radiation Oncology experience is preferred but not required

Regulatory experience

Radiation Oncology 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 2 to 3 years of experience or equivalent combination of education and experience is required for Clinical Research Coordinator B

Bachelor's degree and 4 to 6 years of experience or equivalent combination of education and experience is required for Clinical Research Coordinator C

Strong problem-solving abilities

Excellent written and verbal communication skills

Solid organizational and time management skills

Ability to manage multiple tasks while maintaining strong attention to detail

Capability of working both independently and as part of a team

Knowledge of IRB and human research protection regulations

Regulatory experience is preferred

Radiation Oncology experience is preferred but not required

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

Bachelor’s degree and 4 to 6 years of experience or equivalent combination of education and experience is required for Clinical Research Coordinator C.

Required skills

Clinical trial coordination, Regulatory compliance, FDA guidelines, Clinical Practice (GCP), Informed Consent Form (ICF) guidelines, IRB regulations, Human research protection regulations, Data collection and quality control, Radiation therapy clinical trials

Preferred skills

Regulatory experience is preferred, Radiation Oncology experience is preferred but not required

Experience

2-6 years