Research Program Coordinator

**This position is not eligible to provide Visa Sponsorship.**

The Division of Cardiology is seeking aResearch Program Coordinator who will coordinate several cardiology related sponsored clinical studies. The position will coordinate the implementation of research protocols as well as ongoing administrative processes related to these studies; screen and enroll patients, and provide continued monitoring of these studies ensuring that all protocols are followed and status reporting, billing, and other regulatory components are performed correctly.

Specific Duties & Responsibilities:

• Provide support and coordination for fellows and physicians during the planning phases of new trials. This would include protocol, consent and case report form development through enrollment, study completion and post study closure.
• Accountable for the overall administration and outcomes for trials requiring advanced-level knowledge and skills to manage a diverse portfolio of research responsibilities.
• Daily screening, recruitment, protocol adherence, schedule patient visits and assessments, as well as telephone follow up.
• Assist with preparation of IRB submissions.
• Coordinate all duties pertaining to opening new trials.
• Handle relevant patient biological specimens and follow protocol requirements.
• Blood sample processing to include obtaining specimens by phlebotomy and appropriate handling and labeling.
• Regular attendance at research meetings as well as providing updates on the study progress and issues related to the research.
• Prepare regulatory reports and maintain all regulatory binders for enrolling trials and trials in follow-up phase.
• Prepare and maintain individual participant study binders.
• Adhere to FDA regulatory compliance and regulations.
• Maintain appropriate correspondence with the IRB. Complete and submit IRB Change in Research Reports, including adverse events, protocol deviations and protocol amendments.
• Complete and submit annual IRB continuing review reports.
• Ensure quality, consistency, and accuracy in the conduct of research trials.

• Maintain the research data base including data entry.
• Assist in clinical trial design.
• Assist with consenting study participants and documenting the consent process.
• Assist in data collection including patient contact for enrollment and follow-up.
• Prepare and submit annual continuing review reports.
• Oversee record management for several research studies. Set up database, as well as processing systems and efficiencies for reporting purposes using Excel, Access, or similar systems.
• Oversee budget development, as well as budget expenditures for study operations. Lead and Participate in weekly research conferences.
• Conduct all study close out related procedures including IRB termination reports.

Minimum Qualifications (Mandatory):

• Bachelor's Degree in related discipline required and some experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.