UNIV - Program Coordinator I - Journey - Pediatrics: PRG

Medical University of South Carolina•Charleston, SC

16h•Onsite

About The Position

The Research Study Coordinator will be responsible for providing technical and professional support within the Pediatric Research Group (PRG) on interventional and observational clinical trials. The position will coordinate with the Program Manager, Principal Investigator(s) (PI), and other research personnel involved in human research as delegated. The Research study coordinator will be responsible for serving as the primary coordinator on studies as well as providing back-up or additional support for other PRG coordinators and will involve direct patient contact.

Requirements

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

Responsibilities

Scheduling and conducting study visits and assessments per protocol
Collecting, processing, shipping, and maintaining inventory of research biological specimens
Ensuring timely and accurate data collection following GCP and ALCOA++ guidelines
Maintaining accurate and up-to-date paper and electronic regulatory files
Performing pre-screening activities through screening, medical chart review, and in person discussions with study investigators to aide with recruitment
Preparing and creating essential study documents including worksheets, source documents, and study logs
Assisting with and completing IRB submissions, including initial submissions, amendments, reportable events, and continuing reviews
Serving as the primary liaison between site staff, sponsors, study vendors and other internal departments involved in the conduct of clinical research
Develops recruitment strategies, plans, and tools.
Engages the community, physicians, and identifies barriers to recruitment.
Screens participants for all studies independently (i.e screening for eligibility criteria).
Maintains subject level documentation for all studies independently.
Train others on Good Clinical Practice guidelines related to study documentation.
Independently conducts study visits and may perform complex research assessments.
Extracts complex data from electronic medical records.
May train others to conduct study visits and perform protocol specific testing/interviews.
Collects, prepares, processes, ships, and maintains inventory of research specimens and provides guidance on system improvements related to specimen handling.
Conducts and/or documents consent for participants in minimal risk studies.
May conduct consent for studies greater than minimal risk under direct supervision.
Assists with management and tracking of IP at the protocol and subject level.
Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols.
May be responsible for determining the best methods for handling & documenting IP for investigator-initiated protocols and coordination with investigational pharmacies as necessary.
Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies.
Maintains accurate study registration (Clinicaltrials.gov, etc.).
Independently creates initial regulatory submissions and annual reports to Federal regulatory authorities and funding agencies (NIH, FDA, etc.) for greater than minimal risk studies.
Acts as a site liaison for external IRB submissions and reporting.
Corrects audit/monitor findings independently.
Collects, prepares or processes adverse events under supervision.
Completes IRB and/or Sponsor reportable events independently.
Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
Reviews study participant charges in the medical record and ensures the route according to the Study Billing Plan.
Completes case report forms and enters data into EDC system(s).
Resolves data queries.
Assists with the creation of simple data collection forms (surveys, CRFs, and/or source documents).
Prepares for and participates in team meetings.
Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, Lab, Imaging, NEXUS, and Hospital services, etc.
Under direction provides data for external monitoring reports and/or facilitates completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest.
Understands the ethical conduct of research and safeguards needed when conducting human subjects research activities.
Collects information related to recruitment numbers and resources for study teams to help determine site trial feasibility.
Determines and allocates resources at a study level.
Develops study protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Ensures study teams are compliant with institutional requirements/policies: provides training to staff around these policies and ensures appropriate study specific training plans per Delegation of Authority Logs.
Other duties as assigned