Under the direct supervision of the manager for the Johns Hopkins Brady Urological Institute Biorepository and Service Center, the Research Program Coordinator will assist in the day-to-day logistical and operational tasks of the multiple research studies in the department of Urology. The position will support the conduct of the James Buchannan Urological Institute Biorepository and the Genitourinary Oncology clinical trials, including coordinating start-up activities, scheduling, and preparing for 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. This position will work closely with all members of both the Urology and GU Oncology Programs, including faculty, nurse practitioners, research nurses, administrative coordinators, program manager, and financial managers. The Research Program Coordinator will be responsible for carrying out research in accordance with good clinical practices in activities such as obtaining informed consent, and data and specimen collection.
Specific Duties & Responsibilities
Under the direction of the Biorepository Service Center Manager and/or study PI, coordinate multiple studies, overseeing the implementation of all facets of research protocols for large and complex research studies, and functions as a back-up coordinator on other studies, as required. This includes:
Participate in scientific discussion with collaborators, investigators, and funding organizations to support project planning, study implementation, and study close out
Assist with the creation of eIRB records/submissions for new studies, as well as for continuing reviews, change in research requests, adverse event reports, and other eIRB submission as required by assigned studies.
Create study documents from standard templates and/or adapts sponsor provided documents to meet JHU templates/guidelines
Set up/design protocol implementation tools, including visit checklists, research requisitions, and sample collection trackers.
Ensure study activity completed by other study personnel is completed according to protocol and within the guidelines set forth by the sponsor and JHU.
During the planning stage of studies, play a key role in defining the workflow and study specific operating procedures for assigned studies, including the processes used to identify, recruit, and consent patients.
Prepare for patient visits as related to appointment scheduling, research kit preparation and inventory, and study orders delivery.
Recruit and screen research participants, verify patient eligibility for studies, interview patients, collect patient specimens (e.g., blood draw), vital signs, and other patient data form a variety of sources.
Assist study patients with the scheduling of test and/or follow-up visits.
Assist clinical and research staff with data collection, including but limited to, obtaining medical records, lab results, diagnostic results, visit notes, data entry, and data clarification.
Assist with the preparation of Adverse Event reports and other regulatory documents.
Prepare for and participate in study audits and/or monitoring visits. Interact directly with sponsor staff and/or the staff of regulatory organizations such as the FDA. Provide requested documents and compile requested data into reports as required.
Conduct quality control and assurance for study data, and review and confirm the accuracy of data collected and entered by other study personnel, as required.
Interact with inter-and intra-departmental clinicians and gatekeepers to access the patient populations required to achieve study goals and to eliminate roadblocks that may impede study implementation/completion.
Maintain detailed knowledge of assigned protocols and reporting requirements and adhere to protocol requirements to ensure validity of clinical research data.
Communicate study activity with biorepository manger and departmental finance staff for study invoice development.
Assist with the laboratory processing of patient specimens.
Assist with the development of SOPs and MOPs for assigned studies and participate in the discussion and development of SOPs and MOPs for the service center.
Compile data for reports and presentations, and provide regular study status reports to investigators and/or sponsors.
Learns and follows all study procedures and protocols.
Monitor supplies and coordinate with appropriate persons to have supplies ordered or shipped by sponsor.
Participate in routine group meetings and/or study-specific teleconferences.
Meet regularly with biorepository manager, study PIs and study sponsors to review data accuracy and overall study process.
Prepare IRB communications, monitor and comply with IRB reporting deadlines.
Maintain working knowledge of and complies with the Johns Hopkins Medicine Clinical Practices, ICH Guidelines, and SKCCC Clinical Research Office policies.
Performs general administrative tasks as they pertain to the service center, including copying, scanning, faxing, maintaining office supplies, and all other duties as assigned.
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Special Knowledge, Skills, & Abilities
Phlebotomy training is not required, but prior experience/training is a plus. Candidates without this training must attend phlebotomy training (Training cost will be covered by the department).
Proficient in the use of Microsoft Office (particularly, Word, Excel, and Outlook)
Some prior experience using EPIC, REDCaP, and/or other electronic data collection software/systems a plus (but not required).
Knowledge of medical terminology.
Outstanding organizational skills
Excellent attention to detail
Must have excellent time management skills and able to prioritize workload
Ability to understand and implement support for clinical trials
Ability to manage multiple projects at once, and effectively prioritize each
Requires outstanding verbal communication and interpersonal skills
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contract with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact, and sensitivity.
Specific Physical Requirements:
Ability to stand, walk, or sit for prolonged periods of time.
Ability to lift items up to 20 pounds.
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Some prior experience in a medical related field and/or experience in research.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.75-$23.00 HRLY (Commensurate with experience) Employee group: Full Time Schedule: Monday - Friday/8:30 am - 5:00 pm Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Uro Urology Research Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
*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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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