Clinical/HC Research Specialist - Cardiology

UIOWA•Iowa City, IA

23d

About The Position

Apply clinical skills requiring specialized licensing to independently deliver and evaluate research protocols. The position requires the academic knowledge of a very specialized team and professional licensure in a clinically-related field related to the study. Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility. This role also includes direct patient care involving conducting follow up visits with patients and performing assessments required per protocol.

Requirements

A Master's degree in Nursing or an equivalent combination of education and experience is required.
3 years of related experience is required.
Excellent written and verbal communication skills are required.
A current, valid Iowa Registered Nurse license is required.
Demonstrated knowledge of effective strategies for working with faculty, staff, and students from a variety of backgrounds and perspectives.

Nice To Haves

Experience with clinical trials is desired.
Good clinical practice training.

Responsibilities

Perform clinical/health care research activities and functions as a specialist/technical expert in electrophysiology.
Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
Review new protocols and assign protocols to staff.
Develop, edit, coordinate, manage and maintains specialized electrophysiology study protocols.
Establish study-related metrics for efficiency and success.
Prepare, evaluate and analyze reports.
Review aggregate data from query resolutions and monitor visit reports for all studies.
Responsible for site management and daily activities associated with a clinical trial.
Provide training and guidance; organize and facilitate meetings.
Communicate to health care practitioners, agencies and sponsors.
Function as specialized/technical expert in electrophysiology; perform clinical and data coordination functions associated with subject recruitment, enrollment and data collection.
Coordinate the care of research participants according to protocols requiring a high level of judgment and direct patient care.
Evaluate and analyze data collection procedures.
Update and maintain the requirements and specifications for the electronic data capture systems.
Manage safety of subjects/patients.
Assume responsibility for reportable events reporting, and any corrective actions taken.
Manage and organize regulatory documentation.
Prepare regulatory submissions.
Perform on-site audits of research and clinical data.
Communicate with IRB staff and investigators.
May hire, develop and manage the performance of staff; assure staff is compliant with UI policies and procedures.
Perform administrative tasks to assure completion within specific timelines and budgets.
Develop and administer budget for study(ies).