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The Department of Urology is seeking a **_Research Assistant_** . Under the direct supervision of the Principal investigator(s), this role will monitor the clinical course and collection of research data on patients entered onto research protocols at the division. Responsible for the organization, entry, maintenance and accuracy of all patient's clinical research data in a timely and ongoing manner. Run reports and analyze data to generate specific study findings. The Research Assistant will perform basic laboratory techniques in processing of human tissue/blood sample, cell culture, molecular biology procedures, ordering, and equipment troubleshooting. Manage clinical trials, registry databases, record keeping systems, and procedures. Assists in project planning, and ensures that pre-established work scope, I RB-approved study protocol, and regulatory requirements are followed. Recruits and coordinates research subjects, as appropriate. Assists with writing protocols, papers/publications, and study results.

Specific Duties & Responsibilities

+ Implements and maintains data collection and analysis systems in support of research protocol, including the management of data, paper files, and electronic databases.

+ Oversees day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes.

+ Oversees day-to-day activities in carrying out research protocols, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.

+ Develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators and/or regulatory bodies.

+ Acts as the primary administrative point of contact for Pl's, postdocs, research or administrative staff.

+ Maintains good working knowledge of all assigned protocols and reporting requirements.

+ Transmits and distributes protocol information.

+ Responsible for submission, verification, and maintenance of protocol specific information on the Research Protocol Library, as appropriate.

+ Maintains regulatory binder for each assigned protocol.

+ With assistance, prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements.

+ Adheres to all protocol requirements to ensure the validity of the clinical research data.

+ Assists the Pl in defining information and plans required to accomplish goals of studies.

+ Design and create protocol specific data collection forms.

+ Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.

+ Confirms patient registrations and relevant data points in databases for the Clinical Research Office and Oncology Information Systems.

+ Maintains a research chart for each patient. 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.

+ Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.

+ Verifies and schedules patient appointments, tests, and follow-up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.

+ May design and compile materials which aid physicians/other staff in complying with protocol requirements for study participant/patient visits and tests.

+ Performs structured patient tests in the clinic, observe behaviors and anomalies, and take patient medical and surgical histories.

+ Document stages and changes of medication or condition during course of study and notify appropriate providers.

+ Assists clinical staff in the collection of samples and has detailed knowledge of sample requirements.

+ Transports, processes, and ships study blood and tissue samples, 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 biohazardous materials; monitors inventory of supplies required for studies.

+ Meets regularly with Principal Investigator to review data accuracy and overall study progress.

+ Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.

+ Assist with the writing and editing of manuscripts.

+ Maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries.

+ Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies, patient demographic and clinical data into institutional database as required.

+ Responds in a timely manner to special projects or queries related to the data.

+ Corrects errors in database when necessary.

+ Prepares for and participates in monitoring and audits of studies.

+ Completes minimum requirement for continuing educational units.

+ Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and Clinical Research Office policies.

+ Performs miscellaneous job-related duties as assigned.

Special Knowledge, Skills & Abilities

+ Highly detailed-oriented with excellent organizational and time-management skills.

+ Excellent oral and written communication skills.

+ Excellent work attitude and habits including reliability, flexibility, and the ability to think and work independently and as a team.

+ Ability to follow multiple, detailed directions of various protocols.

+ Excellent oral and written communication skills.

+ Proficiency in PC operations and software application.

Minimum Qualifications

+ Bachelor's Degree in related discipline.

+ Some related experience.

Preferred Qualifications

+ Some related work experience in coordination of medical or laboratory research.

+ Experience in database operations.

+ Scientific writing, generating figures and tables from data, and reading and summarizing research literature.

Classified Title: Research Assistant

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

Starting Salary Range: $17.20 - $30.30 HRLY ($40,144 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: 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