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.

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.

Job Description Summary

This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.

Job Description

"This position is contingent upon available funding"

Screen daily to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists before introducing opportunity to patient. Recruit patients and explain protocol and consent forms. Assure original signed consents are maintained in  study binder, Complete screening/enrollment logs and submit to sponsor, as protocol defines.

Assist in the conduct of clinical research studies performed by physicians using currently approved protocols, according to Good Clinical Practice. Obtain detailed knowledge of all components of study protocols by review of study protocol, related literature prior to study start date. Assure accurate and timely completion & updating of the Delegation of Duties and Authorized Signatures Form. Create & maintain research data, regulatory files, subject data, billing records,

Complete all source documents and worksheets within 48 hours of study activity. Complete and/or enter all clinical record forms (CRFs) within 5 working days or less depending on sponsor requirements. Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs in a timely manner.

Create and maintain a complete and accurate regulatory binder for each study. Assist with preparation and processing of all Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments and adverse event reporting. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms

Schedule and conduct follow-up visits with patients and assure research team availability to assure all follow-up activities are conducted within sponsor designated timeframes including documentation of lost-to-follow-up efforts. Schedule additional protocol-required tests/procedures.

Monitor adherence to protocol throughout patient enrollment in study. Notify PI, RPM, sponsor of any deviations from protocol or adverse events. Assure reported trial data are accurate, complete, verifiable from source documents; collect data on adverse events and reports serious adverse events per regulatory standards. Assure correct version of approved consent is used for each enrollment. Assure timely notification to all enrolled subjects of significant changes in consent.

Other duties as assigned

Qualifications

Bachelor's Degree with 1-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required

Working Conditions

Office, Library, Computer Room; Requires extensive safety

Physical Effort

Typically sitting at a desk or table; Occasional lifting 25 lb. or less

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$36,401.00 - $65,521.00

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.