Under direct supervision of the lab manager and Faculty/Principal Investigator(s), this individual supports clinical trials and research programs. This position is responsible for the coordination and implementation of assigned clinical trials within the research program. Anticipates research requirements for designated patient populations. May collaborate in development & writing of protocols and consent forms, as appropriate. Collaborates in development and preparation of regulatory documents as appropriate.
Applies knowledge of study design to evaluate new protocols. Applies knowledge of federal & local regulations when evaluating new protocols. Coordinates IRB submissions, protocol implementation and monitoring to ensure the collection of data for studies. The range of duties includes, but is not limited to: patient recruitment/ interviews, sample collection from the operating room, data collection, organizing collected information; records management, expenditure oversight, and communicating with team members on the status of project(s).
Working knowledge of research. Utilizing this knowledge, will ensure adherence to research protocols, operating procedures, and all associated internal/external regulations.
Collaborates in the design of appropriate methods for collection of data required for assigned trials. Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable).
Using working knowledge will assist in developing recruitment tools for assigned study(s), which include protocol/study specific data collection forms, drafting and placing approved advertisements, and contacting physicians for possible referrals.
Develop tracking database/spreadsheet based on study requirements utilizing Excel, Access, or similar software applications and work closely with lab residents; attend and participate in clinical research meetings.
Meets with study participants, explains the study, and obtains written consent for their participation.
Communicates with coordinating center and provides necessary documentation (i.e., CVs, 1572, lab licenses, normal values, IRB submissions, etc.) as appropriate. Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents.
Ensures initial & ongoing eligibility of all subjects for assigned research studies. Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes. Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
Abstract data from patient medical records that requires some interpretation. Monitors data quality and accuracy as required by research protocol. Will run pre-established queries and may develop ad-hoc queries/reports as requested.
Evaluates outcomes of clinical trials. Monitors study team compliance with required study procedures & GCP standards. Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, & response.
Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process). Participates in sponsor/cooperative group/internal audits/monitoring. Assists with development & review of institutional SOPs pertaining to performance of clinical research. Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.
Identifies need and incorporates information from other health care disciplines into clinical research protocol. Plans long-term study patient care in relation to identified and potential problems related to assigned research protocols/patient populations.
Utilizing working knowledge of study(s) will participate in meetings to provide operational updates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues. Assist in coordinating study(s) meetings, which may include assisting in developing an agenda and coordinating information and/or participation of individuals from other institutions and/or universities.
Oversee budget expenditures based on the study(s) operational expectation and review with each principal investigator.
Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable). Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate.
Ensure that case files and accompanying paperwork are organized and current.
Ensures initial & ongoing eligibility of all subjects for assigned research studies.
Manage internal IRB database for a PIs.
Be an advocate for the trial.
Other duties as assigned.
Must be a registered nurse, licensed in the State of Maryland or state where practicing.
Bachelor's degree in nursing or related discipline required.
Minimum of two years' experience in the specialty and experience in clinical or laboratory research. Must maintain licensure during the course of employment.
Acceptable completion of the JHH credentialing process is required within two weeks of start.
Related master's degree may be considered in lieu of experience.
* JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. *
Master's degree strongly preferred.
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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