Research Program Coordinator
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: Johns Hopkins University
Research Program Coordinator will coordinate several cardiology related sponsored clinical research 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
- Prepare regulatory reports and maintain all regulatory binders for enrolling trials
- 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):
Required: Bachelor’s degree in related discipline required. Additional 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.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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