Classified Title: CO Research Program Coorinator Working Title: Clinical Trial Research Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.10 - $22.12 (commensurate with experience) Employee group: Full Time Schedule: M-F Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10003206-SOM Uro Urology Research Personnel area: School of Medicine
Under the direct supervision of the Administrative Manager for the Brady Urological Institute, the Research Program Assistant II is responsible for facilitating clinical research patient visits and data collection at the Brady Urological Institute at Johns Hopkins. The position will support the conduct of The James Buchanan Brady Urological Institute Biorepository and other Genitourinary Oncology clinical trials conducted at the Brady Urological Institute, including coordination of start-up activities, the scheduling and preparation for scheduled patient visits, completing the informed consent of patients to approved study protocols, collection of patient biospecimens through standardized procedures, assisting with data collection and clarification, and general administrative duties.
The Research Program Coordinator is responsible for identifying patients for recruitment, evaluating eligibility, assisting with data collection and management, tracking recruitment rates, collecting data at baseline and follow-up (including obtaining medical records for participants), data entry, quality assurance tasks including developing and organizing data reports and maintaining research protocols, processing IRB reports and amendments. The research coordinator works closely with other research staff to ensure that study timelines and goals are met and maintains good working knowledge of all assigned study protocols and reporting requirements. The position also transmits and distributes protocol documents and updates to all members of the research team and maintains and organizes this information. The research coordinator is responsible for responding to questions and concerns as they arise. They work with study investigators and other study staff to prepare and submit annual IRB renewal requests, change in research amendments and adverse event reports according to all participating IRB and Sponsor requirements. Organize and participate in all study meetings and prepares materials for these meetings. Assists study investigators by compiling and preparing study data for reports, publications, and presentations. Provides additional staff support as assigned, including scheduling meetings, generating meeting agendas, preparing minutes, and tracking assignments in between meetings.
The position will support the conduct of the biorepository and numerous studies that utilize its resources to complete study objectives, including scheduling and preparing for patient visits, coordinating the collection of biospecimens from study participants, directly collection biospecimens from enrolled study participants, processing of biospecimens, distribution of collected biospecimens to various collaborators, assisting with data collection and clarification, and general administrative duties. In this role the position will assist with the management of the day to day activities of at least one additional research program assistant (the direct supervisor of both positions will be the Administrative Manager for the Brady Urological Institute). This position will work closely with members of the Brady Urological Institute and the Sidney Kimmel Comprehensive Cancer Center, including faculty, research nurses, other study coordinators, program manager, financial manager, and other research program assistants to ensure that all assigned studies are conducted within the guidelines of both JHMI and sponsors.
On a weekly basis, will review Urology JHOC clinic schedule, Urology OR schedule, and the schedule of other clinical appointments/procedures, that may provide an opportunity to recruit, consent, and collect biospecimens from willing patients, to create a plan for the upcoming weeks collection requirements.
Will guide the day-to-day activities of the Research Program Assistant II through the creation of a weekly case schedule highlighting specific cases that require biospecimen collection and/or other tasks that need to be accomplished in relation to the Brady Biorepository.
Maintains good working knowledge of all assigned protocols, key investigators and collaborators, as well as reporting requirements.
Maintains a study compliance binder for each assigned protocol.
Adheres to all protocol requirements to ensure the validity of the clinical research data.
With assistance, prepares and submits continuing review requests, changes in research amendments, and adverse event reports with clinical input according to IRB and sponsor requirements.
Transmits and distributes protocol documents and updates to all members of the research team and maintains and organizes this information.
Sets up protocol implementation tools, including visit checklists, research requisitions, meal and parking vouchers, and sample collection trackers.
Prepares all necessary documents and reports in preparation of study audits and directly works with the audit team to provide requested documents and reports during the audit.
Plays a key role in creating and implementing corrective action plans related to the results of study audits and/or adverse events.
For all assigned studies the position will serve as the primary person for and/or will assist with data collection, including obtaining medical records, lab results, diagnostic results, visit notes, abstraction and entry of study data, and data clarification.
Works with study investigators to create reports/presentations/publications as related to the results of ongoing and completed studies.
Coordinate the collection and distribution of biospecimens collected from patients who are actively participating in various research studies.
Organizes and participates in study meetings, routine research group meetings and/or study-specific teleconferences.
Performs general administrative tasks, including copying, faxing, maintaining office supplies, and errand running.
Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
Assists departmental finance team by providing regular updates on study accrual and study expenditures to allow appropriate and timely invoicing to study sponsors.
Other patient related duties associated with other ongoing studies include:
Identify patients for study recruitment, evaluate eligibility, consent and enroll patients into study
Work with patients and their other care givers to obtain baseline medical data
Data collection, entry, and management
Track recruitment rates to ensure that the study is on target for enrollment and to ensure that study accrual does not exceed the study budget
Quality assurance: developing and organizing data reports, maintaining research protocols (creation and submission of continuing review, changes in research, adverse event reports)
Assists with reimbursement requests and/or ensuring that study participants are appropriately compensated for participation as allowed by the study protocol.
Bachelor's degree required. Related work experience in coordination of medical or laboratory research required. 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.
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
Special knowledge, skills, and abilities:
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent. It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Any specific physical requirements for the job:
Ability to stand, walk or sit for an extended period of time.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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