Classified Title: [[Sr. Research Program Coordinator]] Working Title: [[Sr. Research Program Coordinator]] Role/Level/Range: ACRP/03/MB Starting Hourly Pay Rate Range: [[$18.52 - $25.47]] Employee group: Full Time Schedule: [[Monday - Friday, 8:00am-4:30pm / 37.5 hrs per wk]] Exempt Status: Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10003311-SOM ICTR Inst Clin Translational Resrch Personnel area: School of Medicine
Under the direct supervision of the Principal Investigator, the Sr. Research Program Coordinator is responsible for the monitoring and collection of research data. The Sr. Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all clinical research data for multiple complex and detailed clinical trials, and may assist with orientation and training of less senior research staff in protocol and clinical research information. Incumbent will be responsible for the coordination and implementation of assigned research projects within the research program and will anticipate research requirements for designated patient populations. The Sr. Research Program Coordinator may collaborate in development & writing of protocols, consent forms and source document worksheets, in development and preparation of regulatory documents as appropriate and clarifying concerns & questions about new protocols with PI &/or sponsor.
This is an intermediate level position in managing research trials and/or registry databases within the Infectious Diseases Research program. The Sr. Research Program Coordinator interacts with the CTSA, the Institute for Clinical and Translational Research (ICTR) nursing staff and faculty, fellows, and staff of various divisions/departments of the Johns Hopkins School of Medicine.
Specific Duties & Responsibilities
Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information to the research team.
Maintains regulatory binders for assigned protocols. Prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
May assist the principal investigator and/or grant/program manager in defining information and plans required to accomplish goals of studies. Will design and create protocol specific case report forms as needed. May also assist less experienced staff in design and creation of such forms.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the PI and Program Manager in grant writings, presentations and publication.
May design and compile materials which aid physicians/other staff in complying with protocol requirements such as source documents.
Meets regularly with Principal Investigator and Research Nurse Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
Will develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management, and will participate data analysis as needed.
Will participate in drafting of manuscripts and grant applications as needed.
Will meet and/or communicate with financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. May participate in the development of invoicing schedules.
Prepares for and participates in monitoring and audits of studies. Writes responses to audit reports with input from the Research Nurse Manager and Principal Investigator.
Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
May assist in study design and contributes to Standard Operating Procedure (SOP).
Schedules study visits and procedures in a timely fashion and in accordance with the study protocols.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Bachelor's degree in related discipline
3 years related experience.
Additional education may substitute for required experience, to the extent permitted by the * 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. *
Clinical trials/medical research experience
Past experience with government and industry funded studies
Experience in a laboratory
JHU Human Subject Research Compliance Training
Phlebotomy Certification; Current CPR certification
Special Knowledge, Skills, and Abilities
Proficiency in the use of common software applications, databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail skills required. Must have ability to manage multiple and competing priorities. Must have excellent time management skills. Must have excellent oral and written communication skills. Must be able to work independently. The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision, and be comfortable being part of a diverse professional team.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact generally require immunization against mumps, rubella, measles, chicken pox and hepatitis B. 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 from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office. Please be aware that should you require vaccination for chicken pox, the vaccine is administered in two doses given six weeks apart. Johns Hopkins University policy is that individuals will be placed off work without pay between the two doses.
Must be familiar with medical terminology. Must be proficient in computer skills.
Must be comfortable contacting people with an outgoing personality and good interpersonal and communications skills. Familiarity with medical terminology and proficiency in computer skills needed. Excellent organizational skills needed to prioritize multiple tasks with attention to detail. Must understand and pass all Johns Hopkins online Human Research Certification courses.
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 firstname.lastname@example.org. 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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