ClinicalHC Research Specialist Cardiology

BASIC FUNCTION:

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.

KEY AREAS OF RESPONSIBILITY:

Research/Clinical Activities:

• 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.

Protocol Development and Study Responsibilities:

• 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.

Subject Recruitment and Enrollment:

• 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.

Data Collection and Monitoring:

• Evaluate and analyze data collection procedures.

• Update and maintain the requirements and specifications for the electronic data capture systems.

Regulatory Guidelines and Documents:

• 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.

Human Resources/Leadership:

• May hire develop and manage the performance of staff; assure staff is complaint with UI policies and procedures.

Financial Responsibility:

• Perform administrative tasks to assure completion within specific timelines and budgets.

• Develop and administer budget for study(ies).