University of Pennsylvania
Philadelphia, PA

Job Details

Duties: Under minimal supervision, responsible for independently coordinating all phases of studies for sponsored research within the Renal-Electrolyte and Hypertension Division, including regulatory and IRB submissions. Identify and recruit subjects to participate in research studies. Involves reviewing patient records, screenings, speaking with patients and maintaining databases of potential participants. Consent, screen, enroll potential study participants and perform study visits per protocol. Schedule patient visits and any necessary testing. Process and ship blood, urine and other specimens for trials. Adhere to all University of Pennsylvania, human research protection, and FDA guidelines. Prepare and process all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Create and maintain master trial file and obtain the appropriate signatures for regulatory forms.

Responsible for conducting study initiation. Responsible for the creation and maintenance of master trial files for +/- 25 clinical studies. Coordinate, organize and maintain all documentation required by sponsor or CRO as it relates to study start-up (source documentation procurement/creation, case report forms, study and regulatory binders, and patient binders). Create and maintain master trial file and obtain the appropriate signatures for regulatory forms. Submits regulatory submissions to the IRB and other research review boards at Penn. Submit renewals and amendment submissions, consent form revisions, continuing reviews, and adverse event. monitoring all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Compliance Oversight for clinical trials; monitoring or auditing of studies with CROs, the FDA and other entities as required for the Division. Work with research teams to prepare for audits including reviewing regulatory binders and performing internal audit and other internal QA activities. Resolve regulatory- related queries with the IRB, study sponsors, and CROs. Develop and maintain standard operating procedures. Maintain a current knowledge of relevant regulations and oversee, revise, and update documentation in order to ensure compliance. Also when indicated, facilitate and perform Central IRB submissions and reviews. Participate in audits by study sponsors, CROs, the FDA and other entities as required for the Division. Represent the division to external organizations (sponsors and CROs) during site selection process, Site Initiation Visits, and study close-out process. Conduct initiation, monitoring and closeout visits with sponsors and/or CROs. Attend Investigator Meetings as the representative for the Division building collaborations with other academic researchers, institutions, and other sponsors. Act as a back up CRC as needed. Perform patient recruitment for sponsored research in the Renal Division. Recruit, screen and enroll potential study patients as specified per protocol. Schedule patient visits and perform any necessary testing. Obtain records required to complete/assess study eligibility

Position is contingent on continued funding.

Qualifications: A Bachelor's Degree and 4 years to 6 years of experience or an equivalent combination of education and experience required.
Knowledge of IRB and Human Research Protection Regulations . Good Clinical Practices (GCP) required, as well as the relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR) and International Conference of Harmonization (ICH) Guidelines. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities, and the ability to build and maintain positive working relationships at all levels of the institution.

Reference Number: 40-30586

Salary Grade: 027

Employment Type: Exempt

Org: DM-Renal-Electrolyte and Hypertension

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.

Job Family: I-Technical/Professional Research


Welcome to the University of Pennsylvania! Penn is the largest private employer in Philadelphia and is a world-renowned leader in education, research, and innovation.  

Across our 12 highly-regarded schools, more than 25,000 students, and more than 4,000 faculty members, we become one university: a wide-ranging, ever-changing community that draws its strength from a multitude of races, ethnicities, genders, sexual orientations, historical traditions, ages, religions, disabilities, veteran status, interests, perspectives, and socioeconomic backgrounds. 

Penn carries on the principles and spirit of its founder, Benjamin Franklin: entrepreneurship, innovation, invention, outreach, and a pragmatic love of knowledge. Franklin's practical outlook has remained a driving force in the university's development. To learn more, visit About Penn



As engines of knowledge and new ideas, universities have the unique potential to define the future rather than be defined by it; to pioneer change rather than merely manage it. To do so requires a plan both visionary and pragmatic. The Penn Compact 2022 motivates community members to innovate, be radically inclusive, and positively impact their local, national, and global communities. 


Penn’s fundamental priorities — increasing access, integrating knowledge and engaging locally, nationally and globally — are supported by the three core values that make us uniquely Penn: inclusion, innovation, and impact. 


Learn about the signature initiatives of the Penn Compact 2022:  




Understanding and appreciating diversity is one of Penn's most important priorities and is fundamental to success in today's world. 


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. 


To learn more about Diversity and Inclusion at Penn visit: 




Penn offers a wide range of benefits and perks - from Penn's retirement Matching Plan to bike repair stations to access to the full LinkedIn Learning library to adoption assistance to workshops at the letterpress and book arts studio and much more! 


Campus and Beyond


We invite you to explore our campus and its stately buildings and state-of-the-art facilities. 


Try our self-guided tour! Come and visit


Learn about sustainability at Penn




Stay up-to-date with Penn's response to COVID-19: Coronavirus Information & Resources


Penn supports news publications that tell the ongoing story of the University community, communications services for external media, telephone and video services, and other media resources: Campus Media 


Connect with us!  


Instagram: @uofpenn 

Twitter: @Penn 



Company info
(215) 898-7372
3451 Walnut Street

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert