Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,536-$52,989 Employee group: Full-Time Schedule: Working 37.5 hours per week; Monday-Friday 8-4:30pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002817-SOM DOM Pulmonary Personnel area: School of Medicine
The Sr. Research Program Coordinator will be responsible for advancing the research mission of the Johns Hopkins Pulmonary Hypertension Program through work on industry and NIH clinical trials. This position will work as a member of multiple multidisciplinary team and with all levels of research personnel including investigators, research nurses, other study coordinators and research assistants.
The Sr. Research Program Coordinator will be responsible for all activities related to a variety of clinical trials as assigned, including: participant enrollment; monitoring the progress of research protocols for multi-center studies; collection, entry, and management of research data on study participants; and, carrying out the day-to-day activities required for meeting the goals of a variety of research projects. Responsible for advancing multiple priorities at once, the Sr. Research Program Coordinator will need strong organizational skills, the ability to easily adapt to change, and a teamwork orientation for successful multidisciplinary collaborations to manage as many as 5 or more active clinical trials at a time, with limited oversight from management.
Specific Duties & Responsibilities:
Work closely with multiple principal investigators and co-investigators to ensure smooth and efficient execution of research protocols
Meet goals of a variety of clinical trials through identifying and enrolling the required number of qualified participants
Schedule patient’s research visits, obtain informed consent, collect and record research data, control data quality and maintain research integrity
Create case report forms for data collection and display data in tables and graphs as needed
Be responsible for the organization, entry, maintenance, and accuracy of all patient clinical research data in a timely and ongoing manner
Process blood samples to be sent to study sponsors
Maintains good working knowledge of all assigned protocols, maintains regulatory binder for each assigned protocol, maintains a research chart for each patient, may assist principal investigator in defining information and plans required to accomplish goals of studies, verifies patient eligibility for studies, and meets regularly with principal investigators and sponsor monitors of studies for review data accuracy and overall progress
Will ensure that the daily operations follow the study protocol and conform to Good Clinical Practice (GCP)
Will be responsible for coordinating serious adverse event reporting with clinicians and investigators to ensure prompt reporting to JHMIRBs and study sponsor
Will complete all required IRB submissions including initial approvals, annual renewals, changes in research, safety reports and protocol deviations and events as required
Ensure appropriate billing and invoicing per study budget
Responsible for timely updating of the CRMS system and the Epic system
Maintains work-related training and certification as required by JHU
Is able to travel when necessary to attend work-related investigator meetings for updates on various protocols
Is able to act as a mentor/leader to other research coordinators and staff
Is able to learn additional skills and knowledge quickly in order to best manage studies as assigned by management
Minimum Qualifications (Mandatory):
Bachelor’s degree in a related discipline.
Minimum of three years’ related experience required. Additional education may substitute for experience, to the extent permitted by the JHU Equivalency Formula
Master’s degree in related field. Advanced training in research coordination (Such as a passing score of the CCRP certification exam)
Special Knowledge, Skills, and Abilities:
Excellent oral and written communication skills and interviewing techniques
Makes decisions and establishes work priorities on essentially procedure-oriented operations.
Knows the informal policies, procedures, and practices necessary to conduct the normal function of a specific section, unit, or work area. Is aware of the role of the position and its potential impact on the working unit.
Technical Qualifications or Specialized Certifications:
Certification as a Clinical Research Professional (CCRP, SOCRA) or Clinical Research Coordinator (CCRC, ACRP) is required. Candidates without this certification will be required to obtain it within six months of hire.
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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