Temp - Clinical Research Assistant

$15,080 - $40,290/Yr

University of Pennsylvania - Philadelphia, PA

Full-time - Entry Level

Philadelphia, PA

Educational Services

About the position

The University of Pennsylvania is seeking a highly motivated and dedicated individual for the position of Temporary Clinical Research Assistant within the Renal, Electrolyte, and Hypertension Division. This role is essential for providing study assistance and coordination for patient-oriented clinical and translational research projects. The successful candidate will work closely with study physicians, coordinators, and other research staff to ensure the smooth operation of clinical studies. The position requires a flexible schedule, which may include early mornings or late evenings, to accommodate study needs. The Clinical Research Assistant will be responsible for a variety of tasks that are critical to the success of the research projects. These tasks include assisting with Institutional Review Board (IRB) documentation, which encompasses submissions, continuing reviews, amendments, and adverse event reporting. The assistant will also be involved in processing, filing, and organizing study and regulatory documentation, ensuring that all necessary records are maintained accurately. In addition to documentation tasks, the assistant will coordinate the creation and maintenance of all logs, spreadsheets, and databases required by sponsors or clinical research organizations (CROs). This includes managing source documentation, case report forms, and patient binders. The role also involves resolving regulatory-related queries with the IRB, study sponsors, and CROs, as well as performing study visits in accordance with the research protocol. The assistant will be tasked with obtaining records and other materials necessary to complete case report forms and comply with the protocols, as well as reviewing electronic medical records (EMR) to extract relevant medical information for the research.

Responsibilities

• Assist with Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting.
• Process, file, and organize study and regulatory documentation.
• Coordinate, create, organize, and maintain all documentation, logs, spreadsheets, and databases required by sponsors or clinical research organizations (CROs).
• Resolve regulatory-related queries with IRB, study sponsors, and CROs.
• Perform study visits per protocol.
• Obtain records and any other material required to complete case report forms and comply with protocols.
• Review EMR records and extract medical information relevant to research protocol.

Requirements

• Knowledge of medical terminology and ability to read lab reports.
• Familiarity working with Penn chart is preferred.
• Ability to work a flexible schedule, including occasional early mornings or late evenings.