Johns Hopkins University Sr. Research Program Coordinator in Baltimore, Maryland
Serves as Sr Research Program Coordinator on sponsored clinical studies in the Broadway Campus Lupus Center. Maintains detailed knowledge of assigned study protocols. Works on complex clinical trials as interventionist, senior coordinator, senior resource, and supervisor of subordinates.
Specific duties & responsibilities:
Responsibilities include familiarity with a range of clinical research conducted in the Division of Rheumatology with primary coordinating responsibility for assigned studies, processing and storing samples collected, contacting and scheduling research subjects, acquisition and verification of data from questionnaires as well as acquisition of results from laboratory and imaging studies, phlebotomy/blood processing and storing of samples collected, ongoing communication between patients and faculty, and ordering supplies
Responsible for the submission, verification and maintenance of protocol specific information
Maintains regulatory binder for each assigned protocol
Prepares and submits annual renewal requests, amendments and adverse event reports to IRB and sponsor with input as required from Principle Investigator.
Ensures adherence to all aspects of protocol requirements to ensure validity of clinical trails
Assists the PI in defining preparatory activities, subordinate staff roles, data collection plans, data entry procedures, communication procedures among study staff, and timely review of summary data to accomplish study goals
Assembles designs and scores study specific instruments as needed for each protocol.
Maintains participant chart for each patient
Collects and compiles information from medical charts and other sources
Designs study database (ACCESS format) and develops quality control procedures to ensure accurate and timely data input
Organizes for and participates in all audits of study procedures
Develops and monitors overall progress of study in relation to study goals
Is very knowledgeable about and instructs and trains all subordinate staff in guidelines related to good clinical practice, IRB regulations, JHU and NIH research policies.
Serves as main liaison with study biostatisticians and data management personnel associated with each project. Participates in design of upcoming studies as well as the preliminary and internal analysis of data, performs statistical calculations and assists with preparation of reports, scientific abstract and manuscripts related to projects.
Minimum qualifications (mandatory):
Bachelor’s degree in related discipline, and a minimum of three years of related experience.
Special knowledge, skills, and abilities:
Excellent organizational skills, high level of attention to detail, ability to manage and prioritize multiple competing activities is essential. Proficiency in the use of ACCESS, Excel, and statistical software programs required. Ability to train and supervise subordinate personnel. Must have excellent interpersonal, as well as oral and written communications skills. Ability to work well with people, including faculty, staff and patients.
Classified title: Sr. Research Program Coordinator
Starting Salary Range: $37,781 - $51,950 (commensurate with experience)
Employee group: Full-Time
Employee subgroup: Exempt
Schedule: Working 40 hours per week; Monday-Friday, 8am-5pm
Location: Johns Hopkins East Baltimore Campus
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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