Research - Laboratory/Non-Laboratory, Staff/Administrative
General summary/purpose: The Research Program Assistant II will be responsible for the logistics of enrolling patients into clinical research studies investigating peripheral neuropathies and types of myositis and their underlying causes and treatments.
Specific duties & responsibilities:
Clinical Research Activities
Assist the principal investigator with multiple clinical research projects. Work on clinical studies requiring a high level of knowledge, coordination and data abstraction
Assist clinicians with patient screening, consenting and verification of patient eligibility for studies
Explain protocol procedures and obtain informed consent
Schedule patients' appointments and follow up visits/phone calls at the appropriate time to assure completion of protocol requirements, which may require coordination of multiple appointments and centers.
Be responsible for organization, entry, maintenance and accuracy of patient clinical research data
Design and compile materials which aid physicians and other staff in complying with protocol requirements
Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
Responsible for monitoring the clinical course and collection of research data on patients entered into research protocols
Collect patient source documents and case report forms for analyzing patient data.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus
Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study and ensure integrity of data collected
Coordinate the collection and documentation of patient information for research purposes.
Organize and create clinical research charts to be reviewed by regulatory agencies
Maintain a research database of patients enrolled in clinical trials
Participate in and or organize community events to increase public awareness
Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements
Maintain regulatory binders per protocols
Document adverse events and protocol deviations
Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements
Responsible for maintaining and promptly updating online Clinical Research Management System
Assist with preparation of data for reports and presentations
Respond in a timely manner to special projects or queries related to data
Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process
Perform quality checks on data entry
Ensure accuracy and timeliness of data collection. Interact regularly and helps facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies
Abstract patient clinical and demographic from a variety of sources and enter into tracking spreadsheet or data base
Assist with writing manuscripts and abstracts for publication
Assist with development of grants, progress reports and study protocols
Research Program Oversight
Meet regularly with Principal Investigators to review data accuracy and overall study progress
Work with the Center Directors and/or study sponsors on problem recognition/resolution, accuracy of data gathered and patient well-being, completion and collection of regulatory documents required by sponsors
Prepare for and participates in audits of studies including follow-up items
Conduct periodic audits under the direction of the Program Coordinator and/or PI
Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials
Minimum qualifications (mandatory):
Requires high school diploma/GED and minimum of two years related experience.
Additional education may substitute for 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. *
Classified Title: Research Program Assistant II Working Title: Research Program Assistant II Role/Level/Range: ACRO40/E/02/CC Starting Salary Range: $14.14 - $19.44 Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Non-Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10003524-SOM Neuro Neuromuscular Personnel area: School of Medicine
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.
Equal Opportunity Employer Note: Job Postings are updated daily and remain online until filled.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.