UNIV - Research Program Coordinator I - Surgery: Transplant Surgery Research

Medical University of South Carolina•Charleston, SC

About The Position

The Clinical Research Coordinator is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Surgery as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices”, and adhere to the MUSC IRB regulations for the protection of human subjects.

Requirements

A bachelor's degree and two years of relevant program experience.

Nice To Haves

Must be able to work independently with minimal supervision.
Must exercise judgment and discretion and establish and maintain effective working relationships.
Must be able to communicate effectively.

Responsibilities

Maintains subject level documentation for all studies independently.
Conducts and assist with study visits and may perform research assessments.
Extracts data from EPIC.
Completes all required case report forms in accurately, completely, and in a timely manner.
Ensure study-required clinical elements and tests are conducted and collected according to the protocol.
Coordinates with research physicians, raters, and other study staff for timely completion of all study activities and ensures all resource areas are available for completion of study visits.
Supervise and manage day to day clinical trial operations.
Schedules study participants, caregivers, and research personnel for study visits in compliance with study protocol.
Transcribes data into case report forms completely and accurately.
Monitors completeness and accuracy of case report forms, and coordinates collection and filing of all source documents.
Performs data entry as per study protocol.
Independently creates regulatory submissions and annual reports to the IRB and completes required supplemental regulatory documents for all studies.
Completes IRB and/or Sponsor reportable events independently.
Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events
Independently obtain and document informed consent.
Maintain accurate informed consent documents for later review.
Recruits study participants per study inclusion and exclusion criteria.
Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA, etc.
Coordinates monitoring visits and completes corrections and queries in a timely manner.
Assists other study teams as needed to meet study requirements and organizational goals.
On-call responsibilities on a rotational basis with others in the department.
Will be a resource for all clinical needs and available to answer study related questions or talk with patients about study participation.
Travel to Sponsor initiated investigator meetings with investigators.
Attend information and training sessions at investigator meetings to ensure compliance with study protocol requirements.