UNIV - Program Assistant - Department of Medicine: Division of Cardiology

Medical University of South Carolina • Charleston, SC

3d

About The Position

Position is responsible for assisting with the coordination of clinical trials in the Division of Cardiology. Will be responsible for adhering to study guidelines, scheduling study visits, abstracting data from medical records and entering it into an electronic database. Regulatory amendments will be regularly submitted and binders kept up to date. Will assist research coordinators with their study-related tasks.

Requirements

• A high school diploma and four years of relevant program experience.
• A bachelor's degree may be substituted for the required program experience.

Nice To Haves

• Experience with EPIC and a background in Cardiology or Clinical care is preferred.

Responsibilities

• Data Abstraction and Management: Collect and deliver all sponsor requested data from medical charts as needed Collect and deliver all principal investigator data abstraction requests as needed Ensure protocol adherence for inclusion/exclusion criteria Participate in and ensure up to date training in each relevant electronic Data Capture System for active clinical trials Ensure all sponsor requested data, whether from medical records or patient questionnaires/interviews, is entered into the corresponding database Process all data queries accurately and in a timely fashion Track and report enrollment goals to plan for each study supported
• Clinical Support: Administer phlebotomy, blood processing, and lab shipping procedures Support patient study visit activities, including capturing patient vital signs, administering questionnaires, coordinating transportation and providing general assistance Provide other patient visit support and assistance as directed by the primary coordinator
• General Administrative Support: Manage CCT Operations inventory and supplies fulfillment Track and monitor team member regulatory and training compliance (CITI, CVs, etc.) Participate in process improvement projects as needed Participate in other duties as assigned by supervisor
• Participant Screening: Conduct screening activities for potential subjects according to each IRB approved protocol on various clinical trials Refer potential subjects to the lead coordinator of the study
• Regulatory Compliance and Documentation: Prepare and submit protocol amendments, reportable events, and continuing reviews on a regular basis for the studies you are assigned to File all IRB approval and submission documents, sponsor correspondence, newsletters, and other pertinent information in study-specific regulatory binders and ensure these remain up to date

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED