UNIV - Program Coordinator I - Department of Medicine: Division of Cardiology

Medical University of South Carolina•Charleston, SC

3d•Onsite

About The Position

This individual will be responsible for ensuring adherence to study guidelines, coordinating study visits, ensuring participants meet stringent clinical inclusion guidelines, and providing education to patients and their families. The candidate will be responsible for all regulatory aspects of multiple studies, maintaining study databases, completing study documents, recruiting study patients, communicating with Principal Investigators and sponsors, as well as preparing and conducting audits.

Requirements

Excellent communication and research skills.
Strong computer skills (EPIC, Word, Excel, database software, web based activities, email).
Knowledge of MUSC IRB policies and procedures is necessary.
CCRT certification
Shipping hazardous materials certification
Experience coordinating clinical trials that involve drugs, devices, and procedures is necessary.
Excellent time management
Ability to work independently
A bachelor's degree and two years of relevant program experience.

Nice To Haves

CITI certifications in Biomedical Research and Good Clinical Practice

Responsibilities

Maintain up-to-date knowledge of all assigned research projects.
Review, evaluate and report to PI and Research Manager on a monthly basis, as to study status.
Perform research activities: subject recruitment, consent, and research visits according to study protocol.
Collaborate with all members of the research team in developing and implementing strategies for effective management of research studies.
Independently Schedules Complex, Multi-step Study Procedures.
Coordinates with multiple departments, physicians, and sponsor for research procedures.
Participates in feasibility and logistical planning for new and ongoing studies.
Independently manage study-specific data and identify data discrepancies.
Coordinate/perform the reporting and communications with the IRB and the study sponsor as relevant to research protocols, study implementation, adverse events, ongoing study updates, and other activities necessary for exceptional performance from study activation to close out.
Assist PI in completing initial IRB submission and all Amendments as necessary.