- Time Management
- Microsoft Word
- Clinical Trials
Will be involved in writing protocols for data tasks, data collection, entry, and management functions in clinical research studies.
Specific duties & responsibilities:
Monitor compliance with data quality assurance and quality control goals of clinical studies and follows all written and unwritten study practices, procedures and protocols
Maintains detailed working knowledge of assigned protocols; design and compile materials which aid investigators and other research staff in complying with protocol requirements.
Works on clinical studies, which requires a high level of knowledge and coordination
Ensures accuracy and timeliness of data collection entry, management and analyses.
Prepares weekly report of work hours and activities for review by supervisor
Data entry, management and calculations using computerized database, word processing and spreadsheet software
Performs data management and analyses, including advanced use of excel spreadsheets and Access databases for various studies.
Abstracts patient clinical and demographic data from a variety of sources (including paper and electronic medical records from multiple study sites and multiple electronic platforms) and enters into a CRF, tracking spreadsheet or database.
Conduct standardized assessments of patients via in-patient, clinic or home visit
Able to effectively prioritize and work on multiple tasks with concurrent deadlines and demonstrate excellent time management skills and efficiency
Work independently to ensure successful completion of the clinical research study.
Teaches new staff study procedures
Works with co-workers and students/trainees in prioritizing work flow when necessary for optimizing efficiency and productivity
Proactively seek to improve or optimize work flow and discuss with coordinator/supervisor as appropriate
Have initiative in anticipating and responding to staff and research subjects’ needs based on awareness of routine and repeated job functions
Analyzes research data and performs literature searches for research, presentations, and publications.
Interacts regularly with members of the research team regarding data management and the status and progress of ongoing studies.
Actively communicate and update supervising study coordinators and/or investigators on patient enrollment and data collection status via verbal and written communication
Utilizes good clinical research practices.
Assist in preparation of data and reports for IRB, funding agencies, and other research sponsors.
Write summary reports for specific studies.
Administer standardized surveys to research subjects or their proxies via phone, or via in- patient, clinic or home visits
Schedules research patients’ appointments and follow-up visits/phone calls at the appropriate time to assure completion of protocol requirements.
Prepares and submits annual renewal requests and amendments according to institutional guidelines.
Demonstrates and serves as a role model for a positive work environment, including high motivation, positive attitude, and good judgment, tact, and sensitivity in all interpersonal interactions with all research staff, investigators, students and participants
Call patients with reminders of their appointments
Maintain logs of patient screening, surveys and visits
Maintain compliance with HIPAA and IRB regulations and guidelines
Attend regular research group meetings (weekly or monthly)
Communicate with study sponsors, coordinators and collaborators
Escort patients through hospital during their research visit; set up and take down equipment for patient testing
Organizes, creates and maintains clinical research charts and maintains filing system for electronic and paper-based research records
Coordinates the collection and documentation of patient information for research purposes.
Establishes calendar of various tasks and coordinates the logistics needed for successful completion of the studies.
Literature search & organize data for research manuscripts
Verifies patient eligibility for studies. Identifies study participants and is involved in their recruitment process on various clinical trials.
Experience with the consenting process, ability to explain protocol procedures and obtain informed consent.
Documents adverse events and protocol deviations.
Minimum qualifications (mandatory):
Bachelor's degree in related discipline required. Some related experience required. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Database and spreadsheet knowledge
Special knowledge, skills, and abilities:
Excellent verbal communication skills and good written communication skills. Attention to detail. Strong interpersonal skills and excellent organizational and time management skills required.
Position requires flexibility. Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills, ability to use personal computer; proficiency in Microsoft Word and Excel. Excellent oral and written communication skills required.
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.
Any specific physical requirements for the job:
Sitting in a normal seated position for extended periods of time Standing and/or walking for extended periods of time
Assisting patients during evaluations within crowded clinical environment
Reaching by extending hand(s) or arm(s) in any direction
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard
Communication skills using the spoken word Ability to see within normal parameters Ability to hear within normal range
Ability to move about Ability to lift 20 lbs.
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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