Senior Research Program Coordinator
Under the moderate supervision of the Principal Investigator, the Sr. Research Program Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols in Pediatric Hematology. The Sr. Research Program Coordinator will be responsible for conducting studies with subjects with a variety of hematologic diagnoses. The Sr. Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials, and may assist with orientation of less senior research staff in protocol and clinical research information. This is an intermediate level position in managing clinical trials and/or registry databases within the research program.
- Maintain good working knowledge of the principles, concepts, and theory involved in the research for assigned protocols and reporting requirements of the studies. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information.
- Develop and maintain regulatory binders for each assigned protocol. Prepare and submit annual renewal requests, amendments, and adverse event reports with clinical input in accordance to IRB and sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
- Utilizing working knowledge will assist the principal investigator and/or nurse manager in defining the study design, contribute in the development of standard operating procedures, including recommending changes to the operational procedures based upon results, in order to accomplish goals of studies.
- Design and create protocol specific case report forms, as needed for the different studies. Will assist less experienced staff in design and creation of such forms.
- Utilizing working knowledge, verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
- Develop and maintain moderately complex tracking database/spreadsheet based on study requirements in order to create research chart for each patient. Utilizing Excel, Access or a similar software packet for analyzing the statistical data.
- Using data collection instruments and protocols, in collaboration with study investigator, oversees the collections, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information is completed for physician use in treatment planning, presentations, and publication(s).
- Using working knowledge of the studies, ensures scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. Design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
- Meet regularly with Principal Investigators, Nurse Practitioner and other team members to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
- Develop reports on individual patients or the study as required by the principal investigators and/or external agencies. Respond in a timely manner to special projects or queries related to the data.
- Prepare for and participate in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator.
- Complete minimum requirement for continuing educational units. Knowledgeable/complies with Good Clinical Practices, and ICH Guidelines.
- May instruct introductory level clinical research personnel in these guidelines and policies.
Bachelor's degree in related discipline. Requires a minimum of three (3) years related experience.
Proficiency in the use of software applications, databases, spreadsheets, and word processing. Excellent organizational skills. Excellent attention to detail skills. Knowledge of medical terminology. Familiar with medical procedure and laboratory fees. Ability to manage multiple and competing priorities. Knowledge of clinical research practices and principles. Ability to understand a clinical trial financial contract. Must have excellent time management skills. Must have excellent oral and written communication skills.
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. Additional related experience may substitute for required education on the same basis. 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.
Starting Salary Range: $32,822-$45,116
Employee Group: Full-Time
Schedule: Monday-Friday, 37.5 hrs/wk
Employee Subgroup: Exempt
Department Name: Pediatrics
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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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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