Research Program Coordinator

Requisition #: 314183

Range: CD

Level: 3

Salary: $15.47 - $21.26

Status: Full Time

School: School of Medicine

Location: School of Medicine Campus

Location City: Baltimore

Location State: MD

Resume Required for Application: Yes

Area of Interest: Research / Lab

Contact: 410-955-2990

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General Description

Department: Hematology
Work Schedule/Hours: Monday-Friday 8:30a.m.-5:00p.m. 40 hrs.

Under the direct supervision of the Principal Investigator the Research Program Coordinator is responsible for monitoring and collecting research data for complement associated diseases in the Division of Hematology. The diseases being studied include atypical hemolytic uremic syndrome, antiphospholipid antibody syndrome, HELLP syndrome etc. The 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. The Coordinator will help with consenting, collecting research samples and delivering them to the lab, and helping to prepare monthly data reports to the PI and collaborating investigators. He/She may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an intermediate level position in managing research trials and registry databases within the research program.

Duties and Responsibilities:

Oversee and conduct recruitment, screening and enrolling of eligible patients into laboratory protocols. Explain the protocol in detail and conduct informed consent procedures with potential research participants. Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction. Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data. Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed. Assist less experienced staff in design and creation of such forms. Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.

Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication. Design and compile materials which aid physicians/other staff in complying with protocol requirements. Meet regularly with Principal Investigator to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials. Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management. Participate in data analysis as needed. Meet with department financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Participate in the development of invoicing schedules. Prepare for and participate in monitoring and audits of studies. Write responses to audit reports with input from the Principal Investigator. Complete 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. Perform all other duties as assigned.

Qualifications

Bachelor's degree in related discipline. 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. 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.

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.

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.

Preferred Qualifications

Experience with working and interacting with patients of at least one year strongly preferred.


NOTE: 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 School of Medicine HR Divisional Office at 410-955-2990. For TTY users, call via Maryland Relay or dial 711.

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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