Research - Laboratory/Non-Laboratory, Staff/Administrative
The Sr. Research Program Coordinator will serve as a member of a coordinating center for multicenter clinical trials within the Department of Epidemiology. The coordinating center is involved in the design, conduct, and analysis of multicenter clinical trials that evaluate treatments for asthma and COPD for the ALA Airways Clinical Research Centers (ACRC) data coordinating center. Current studies include a study of impact of COVID-19 pandemic on individuals with COPD; a large (N=4,000) cohort study of lung health in young adult; and an interventional of a medication management program for young adults with asthma. Because our studies focus on respiratory health and disease, all of our studies are implementing data collection on the impact of COVID-19 on study participants. The multicenter network includes over 40 clinics across the United States and receives infrastructure support from the American Lung Association. Individual studies are funded by grants from the NIH and industry. The coordinator would be joining a team of approximately 15 faculty and staff members. The position provides a unique opportunity to learn about different aspects of clinical trial management and to work in an environment that encourages personal growth.
Specific Duties & Responsibilities
Maintains good working knowledge of all assigned protocols and reporting requirements.
Works on complex clinical studies which require a high level of knowledge and coordination.
Transmits and distributes protocol information.
Help maintain IRB approval for studies using single IRB mechanism and local IRB model
Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to single IRB and Sponsor requirements.
May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies.
Design and create protocol‑ specific case report forms as needed.
Responds in a timely manner to queries related from study sites.
Participates in monitoring and audits of studies and generate site performance reports.
Reviews audit responses from study sites and works with site to ensure database are updated; corrects errors in database when necessary.
Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and ALA-ACRC policies.
May instruct introductory level clinical research personnel in these guidelines and policies.
Write and distribute correspondence to study sites
Order and distribute study supplies to study sites
Create meeting materials and assist in their publication
Create and manage online surveys to coordinate scheduling of large meetings or gather information needed for planning multicenter studies
Attend Steering Committee and Executive Committee meetings and prepare minutes
Serve as liaison with study site personnel regarding data quality issues and study procedures
Review and maintain certification material for overall site and site personnel certification
Maintain status of site certification and alerts sites and DCC to deficiencies
Assist in development and implementation of training modules for site personnel
Write, revise, and assist in the publication of study documents such as manuals of procedures, informed consent statements, and policy and procedure memoranda
Participate in site visits
Conduct data-audits and monitor issues such as study drug management and supplies at sites
Bachelor's degree in related discipline required. 3 years related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. 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.
Special Knowledge, Skills, and Abilities
Strong computer skills to include familiarity with PCs and common software such as Word, Excel, and PowerPoint
Working knowledge of REDCap
Good communications skills, including excellent writing and editing skills
Strong organizational skills
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920 - $53,520; Commensurate with experience Employee group: Full Time Schedule: Monday-Friday, 8:30 am - 5:00 pm, Up to 37.5 hours per week Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 10001101-Epidemiology Personnel area: School of Public Health
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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