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Under the direct supervision of the Manager for the Johns Hopkins Brady Urological Institute Biorepository and Service Center, we are seeking a **_Research Program Coordinator_** who will assist in the day-to-day logistical and operational tasks of multiple research studies in the Department of Urology. The position will support the conduct of the James Buchanan Brady 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 the all members of both the Urology and GU Oncology Programs, including faculty, nurse practitioners, administrative coordinators, study coordinators, program manager, and financial manager. 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 and Responsibilities

+ Serve as a lead coordinator assisting with the training of new staff; coordinate and participate in the training of new research staff on study protocols, procedures, and reporting.

+ Under the direction of the Biorepository Service Center Manager and/or PI, coordinate multiple studies, overseeing the implementation of all facets of research protocols for large and complex research studies, and function as a back-up coordinator on other studies as required.

+ Participate in scientific discussions with collaborators, investigators, and funding organizations to support project planning.

+ Under the direction of the Biorepository Service Center Manager and/or PI, 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 submissions as required by assigned studies.

+ Under the direction of the Biorepository Service Center Manager and/or PI, create study documents from standard templates and/or adapts sponsor provided documents to meet JHU templates/guidelines.

+ Under the direction of the Biorepository Service Center Manager and/or PI, set up/design protocol implementation tools, including visit checklists, research requisitions, and sample collection trackers.

+ 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.

+ 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.

+ 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 completion.

+ 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 from a variety of sources.

+ Assist study patients with the scheduling of tests and/or follow-up visits.

+ Assists 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.

+ Under the direction of the Biorepository Service Center Manager and/or PI, ensure study activity completed by other study personnel is completed according to protocol and within the guidelines set forth by the sponsor and JHU.

+ Compile data for reports and presentations and provide regular study status reports to investigators and/or sponsors.

+ Under the direction of the Biorepository Service Center Manager and/or PI, 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.

+ Assist with the preparation of Adverse Event reports and other regulatory documents.

+ Prepare for and participate in study audits and/or study 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.

+ Assist with laboratory processing of patient specimens.

+ Maintain detailed knowledge of assigned protocols and reporting requirements and adhere to protocol requirements to ensure validity of clinical research data.

+ 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 progress.

+ Prepare IRB communications, monitor and comply with IRB reporting deadlines.

+ Communicate study activity with biorepository manager and departmental finance staff for study invoice development.

+ Maintain working knowledge of and complies with 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.

Special Knowledge, Skills, and 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.

+ Knowledge of medical terminology.

+ Outstanding organizational skills.

+ Excellent attention to detail skills.

+ Must have excellent time management skill.

+ 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.

Technical Qualifications or Specialized Certifications

+ Phlebotomist Certification.

Specific Physical Requirements:

+ 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.

Minimum Qualifications

+ Bachelor's Degree in related discipline with some related experience.

Classified Title: Research Program Coordinator

Job Posting Title (Working Title): Research Program Coordinator

Role/Level/Range: ACRO40/E/03/CD

Starting Salary Range: $17.20 - $30.30 HRLY ($23.75/hour targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Monday – Friday, 8:30 A.M – 5:00 P.M.

FLSA Status: Non-Exempt

Department name: 10003206-SOM Uro Urology Research

Personnel area: School of Medicine

The listed salary range represents the minimum and maximum Johns Hopkins University offers for this position, based on a good faith estimate at the time of posting. Actual compensation will vary depending on factors such as location, skills, experience, market conditions, education, and internal equity. Not all candidates will qualify for the highest salary in the range.

Johns Hopkins provides a comprehensive benefits package supporting health, career, and retirement. Learn more: https://hr.jhu.edu/benefits-worklife/.

Equal Opportunity Employer

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.

EEO is the Law

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf