General Description Department of Medicine, Division of Infectious Diseases
Work Schedule/Hours: Monday-Friday/8:30-5:00pm/40 hours per week
Under the direct supervision of the Research Nurse Manager and/or Principal Investigator(s), the Research Program Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Division of Infectious Diseases at the Johns Hopkins Bayview Medical Center.
The Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner, and may also assist in laboratory experiments associated with research protocols. These data will be used to generate specific study findings after the data is analyzed. This is a position in managing clinical trials and/or registry databases. The Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy related to sample acquisition and clinical/research data for large multi-center research projects. He/she will work with faculty and staff members to prepare and submit IRB proposals and renewals, amendments and adverse event reports according to all participating IRB and sponsor requirements.
Duties and Responsibilities:
1. Maintain good working knowledge of all assigned protocols, research guidelines, and FDA regulations.
2. Assists clinical staff in the collection of specimens and has detailed knowledge of specimen requirements. Transports, processes, and ships specimens as assigned. Operates basic laboratory equipment; complies with biohazard safety standards through proper handling of hazardous chemical and biological agents; uses sterile techniques to avoid contamination; uses universal safety precautions to protect self and co-workers from bio hazardous materials
3. Prepares specimen collection kits, labels and requisitions
4. Monitors inventory of supplies required for studies. Orders supplies and makes check requisitions for research subjects and vendors
5. Performs subject recruitment and preliminary phone screenings
6. Maintains a research chart for each subject. 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 physician in treatment planning for individual patients, presentations and publication.
7. Maintains and updates protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries. Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data.
8. Assists in the compiling and maintenance of regulatory binders for each assigned protocol. Independently or with assistance, prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and sponsor requirements. Ensures that all clinical data adheres to all protocol requirements to ensure the validity of the clinical research data.
9. Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.
10. Maintains appropriate research training and certifications as required by the protocols, sponsor, and regulatory bodies such as the IRB
11. Travel and represent Johns Hopkins University at study investigator meetings and conferences.
12. May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol- specific data collection forms with assistance.
13. Meets regularly with Principal Investigator, Sub-Investigators, Research Nurses and Research Assistant to review data accuracy and overall study progress. Participates in all mandatory meetings and teleconferences to develop increasing knowledge of assigned clinical trial and Registry requirements.
14. Works closely with the Research Nurses and Research Assistant to accomplish the team goals and objectives.
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.
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.