UNIV - Clinical Research Assistant - Department of Medicine: Division of Pulmonary

Medical University of South Carolina • Charleston, SC

1d

About The Position

The Clinical Research Assistant is responsible for visit coordination, careful pharmacy and laboratory management, support for both inpatient and outpatient research patient visits, as well as general administrative and technical support to the program and staff.

Requirements

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

Responsibilities

• Responsible for meticulous and careful pharmacy and laboratory management for clinical trials, including, but not limited to: receiving study drug and/or device shipments; managing IVRS/IWRS/IXRS forms; documenting receipt, dispensation, return, destruction and quarantine of investigational product/devices when applicable in pharmacy binder; monitoring temperature control; acting as the Investigational Drug Services (IDS) liaison for the Pulmonary & Critical Care and COVID-19 Clinical Research Program; providing education on the pharmacy process to the research team; meeting and reviewing pharmacy documentation with the research monitors. Will also be responsible for preparing IP accountability files for on-site monitoring visits, sponsor audits and regulatory authority audits, as well as reconciling and resolving action items following said on-site visits. Prepare lab kits for upcoming visits, monitor the inventory of lab kits and supplies, discard of expired kits, monitor/order general lab supplies, and manage lab requisitions. Maintain and update laboratory binders with new information during the course of the study.
• Works with the Recruitment Team with prescreening potential subjects for clinical trials. Must become efficient at understanding study criteria for enrolling in the clinical trials. Works with Recruitment Coordinator and care team to appropriately identify the eligible trials. Must review medical records to confirm inclusion and exclusion criteria for protocols. Under direction of the investigators and Recruitment team, will contact and schedule potential subjects. Provides information to potential subjects regarding the trials.
• Assists research coordinators and management with subject-related activities as needed including: escorting research patients around campus, conducting minor visits (non-interventional trials), transporting research supplies to the ICUs and other inpatient units, performing clinical assessments such as EKG, PFT, 6MWT, vitals monitoring, data entry, and other research procedures as dictated by the protocol; processing, storing, and shipping laboratory specimens within acceptable guidelines; completing subject reminder phone calls; rescheduling subject appointments as necessary; retrieving external medical records; completing initial medical history review of subjects; managing shipments of study related items to and from subjects and CRO/sponsors. Assist in phone study visits and scheduling of research patients; helps with managing the COVID-19 research email inbox; prepares and sends research shipments and conducts inventories for COVID-19 trials being conducted within the MUSC Regional Health Network.
• Provides research administrative support to each of the research protocols and staff including, but not limited to: providing support to the regulatory team members through various tasks (such as obtaining signatures from providers across campus), assisting in any events, meetings, and trainings for the program by scheduling rooms, arranging catering, taking minutes, and making copies as needed; sorting, delivering and stocking all mail, shipments, and faxes daily; providing phone coverage as needed; tracking inventory of all supplies and ensuring appropriate level of supplies are maintained. Provides support to Research Coordinators by: serving as liaison to CRO/sponsor visitors while on-site or remote monitoring of a study; preparing binder carts for said visitors prior to arrival; ensuring monitor supplies are available and stocked on cart; working with CRO/sponsor representatives to resolve discrepancies; collecting binder cart and investigational product/devices from monitor immediately after his/her departure from the site. Maintains, inventories and archives program equipment and resources by: scheduling annual calibration of all equipment; setting up new equipment and logging each item as received; trouble shooting equipment as needed; addressing day-to-day issues that may arise; tracking storage of completed studies; building binders for each new clinical trial; filing documents associated with each study.
• Perform other duties as required.

What This Job Offers

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