Research - Laboratory/Non-Laboratory, Staff/Administrative
Will be responsible for program reporting activities for the Johns Hopkins Stroke Recovery Center, including quality management measures. Under the supervision of the Director of Center, the research data manager will be the key person who will interact with clinical investigators, program managers, and research coordinators, data analysts and programmers, to facilitate the collection and integration of data from multiple sources. The primary activities of this position are data abstraction, entry, data curation, data quality, and management of research data in the data base, will integrate and verify clinical data with environmental data and bio specimen information, will conduct confirmation emails with clinical staff for data verification. Will also perform preliminary data analysis to be reported to the Center team.
Specific Duties & Responsibilities:
Manage the REDCap data collection platform and prepare reports to assess the studies progress and preliminary analysis.
Design and maintain summary reports for staff use and/or for internal and external communication.
Reviews program reporting requirements and current data collection systems in order to ensure efficiency; design source and output documents; develop reporting schedules to conform to the contract deliverables; provide training for staff members and students/trainees when new procedures are implemented.
Interacts with the Institutional Review Board to assure that data collection
May help design and create protocol‑ specific data collection with assistance.
Maintains good working knowledge of all assigned protocols and reporting requirements.
Maintain a log of eligible and non-eligible patients; request clarification from clinical and research staff if uncertainty regarding eligibility; promptly notify clinical and research staff of eligible patients.
Confirms clinical relevant data points in databases for stroke recovery measurement.
Ensures accuracy and timeliness of data so that information may be used by the Program Manager or Principal Investigator in presentations, reports and publication.
Data quality and management using REDCap, electronic database and other computer software:
Performs and oversee chart reviews and other data quality activities.
Assist with web site maintenance, IT trouble shooting, coordinate with MNET if needed.
Perform routine data backup
Perform and oversee data audits comparing database with data collection instruments
Assist staff with computer and database tasks
Perform ad hoc data entry
Track and assess quality and completeness of data entry and abstraction; immediately raise potential concerns with study managers/supervisors.
Cleaning incoming data files, integrate data files into the data management system, update summary files, process data requests from scientific investigators ensure data quality through the execution of computer programs, development of protocols, and other quality assurance,
Design database in REDCap, ACCESS, or other database management system. Perform queries and generate forms.
Detect problems in research instruments, data collection, and data entry.
Provides technical assistance and training to the staff who may be required to data enter/quality review information that is uploaded to REDCap.
Coordinate and oversee the moving of REDCap cross-sectional and longitudinal data collected to a centralized network periodically and ongoing management of the REDCap system and other program updates (fitbit, actigraph, apnealink, etc).
Establish a working relationship related to the Information Technology (IT) data management requirements with the local JH IT staff as well as the East Tennessee University group.
Reports, internal communication, updates and other coordination:
Review procedures for the reporting of data; institutes methods of monitoring information/external dataset received with respect to timeliness, completeness and accuracy; designs and implements procedures and programs to update information using the REDCap platform or other similar as needed.
Performs evaluation and preliminary analysis of data; prepares routine reports documenting results of findings; creates reports using MS Access, Excel, Word, or PowerPoint; may participate in formal or informal presentation of findings.
Generate graphs, funder reports, and scientific meeting presentations. Prepare manuscripts for publication.
Generate weekly reports of recruitment and retention progress, biweekly/monthly QC report of data collected at the clinic and home visits.
Regularly update clinical and research staff, verbally and in writing, of progress with job functions.
Report periodically progress and completion of tasks to R.P. Manager and PI, and request confirmation of priorities/timeline/deadlines.
Schedule, participate and organize weekly progress meetings of current research projects to report on recruitment progress, data entering and resolve problems, taking notes, minute's .and preparing agenda for next meetings.
Communicate effectively and cooperate with both clinical and research who are directly and indirectly involved in the project in order to achieve project goals in an efficient and effective manner.
Able to prioritize and work on multiple tasks with concurrent deadlines and utilize good time management.
Meets regularly with Principal Investigator, Research Supervisor, and Research Program Manager to review data accuracy and overall database progress.
Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.
Responds in a timely manner to special projects or queries related to the data.
Ability to think critically and to solve problems that arise related to study protocols.
Minimum Qualifications (Mandatory):
Bachelor's degree in related discipline required.
Three years of related experience required.
Knowledge of medical terminology preferred.
Experience working with electronic database such as Recap and SQL preferred.
Experience working with data analysis software
Special knowledge, skills, and abilities:
Experience working with electronic database such as Recap and SQL.
Ability to follow multiple, detailed directions of various data collection
Able to work in teams
Excellent time management skills
Ability to use personal computer; proficiency in Microsoft Word and Excel Access, and Power Point; database and spreadsheet knowledge.
Excellent oral and written communication skills and interviewing techniques required.
Detail oriented, Strong interpersonal skills and excellent organizational and time management skills required.
Position requires flexibility.
Experience working with clinical data collection is desired.
Experience in data management, data collection and clinical trial is desired
Data analysis skills using statistical software : SAS, R or STATA desired
Technical qualifications or specialized certifications:
Required: All IRB-required courses must be completed and appropriate exams passed with necessary certification within 2 weeks of start date.
Classified Title: Research Data Manager Working Title: Research Data Manager Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,195 - $62,225 Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003515-SOM Neuro Cerebrovascular Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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