We are seeking a Research Program Coordinator who will coordinate several cardiac surgery related sponsored clinical studies in coordination with the cardiac surgery clinical trial nurses. This role is a critical component to the success for the cardiac surgery clinical trials program. 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
Assist with preparation of IRB submissions.
Coordinate all duties pertaining to opening new trials.
Handle relevant patient biological specimens and follow protocol requirements
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.
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.
Bachelor's Degree in related discipline.
Some related 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.
*Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.75-$23.00 HRLY (Commensurate with experience) Employee group: Full Time Schedule: M-F 8 - 4:30 Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Sur Cardiac Surgery Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
The successful candidate(s) for this position will be subject to a pre-employment background check.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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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