Clinical Research Coordinator B

2 weeks ago

Eye, United Kingdom University of Pennsylvania Full time

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. 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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn’s vaccine requirements, visit the

Penn COVID-19 Response website

for the latest information.

Posted Job Title

Clinical Research Coordinator B (Department of Ophthalmology)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors coordinators and research assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials.

The primary responsibility of the Clinical Research Coordinator B (CRCB) in the Department of Ophthalmology is to implement one or more industry sponsored, NIH or investigator initiated clinical trials assuring each study is conducted per protocol and adheres to ICH/GCP guidelines. The CRC B will be responsible for preparing IRB submissions, annual continuing reviews, protocol amendments, safety reports, and IRB closeout reports.

**Job Description**:
Job Responsibilities

The CRC B provides regulatory assistance to more junior clinical research coordinators, meets with external and internal study monitors as needed, participates in audit preparation, maintain records in audit ready condition, track patient visits and procedures for confirmation of proper billing process, documents research required training for staff and investigators (HIPAA, ICH/GCP as well as protocol specific training). He/she will prepare new protocol submissions to local Penn IRB, Central IRBs, Penn Medicine's CHPS and IDS. The CRC B will negotiate informed consent documents with external study sponsors and will assist in preparing documents for investigator initiated studies (consent forms, safety monitoring plans, investigator brochures, safety reporting etc). The CRC B will collaborate with leadership to assure readiness for site audits and will participate in study monitoring and close out visits. Oversight of investigational product storage and dispensing under the supervision of the investigator. The position will also perform blood, and biosample collection, storage and shipment from study participants. Assist technicians and photographers with protocol certification and submission of study required data.

**Qualifications**:

- Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$43,919.00 - $66,183.00

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 c

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