Classified Title: Research Program Coordinator Working Title: Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.10-$22.12 (commensurate with experience) Employee group: Full-Time Schedule: Working 40 hours per week; Monday-Friday Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002805-SOM DOM Cardiology Personnel area: School of Medicine
Research Program Coordinator 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 clinical studies. This would include protocol, consent, 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.
Acquire and handle relevant patient biological specimens (blood and tissue samples) 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 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 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
Education and Experience:
Required: Bachelor's degree in related discipline required. Additional experience may substitute
Minimum Qualifications (Mandatory):
BA/BS in related discipline required and some experience. (Relevant employment experience may substitute for some education) 2 years' experience in clinical or medical research setting strongly preferred. Ability to work independently and manage multiple tasks, detail orientated, self-motivated. Ability to be flexible in work conditions, hours and work well in team setting. Proficiency in word processing, Database, and spreadsheet software- ability to use a laptop and personal computer. Possess excellent oral and written communication skills- interviewing techniques required. Excellent organizational skills, strong interpersonal skills and ability to multitask
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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