Under direct supervision of Division Administrator and Principal Investigator(s) supports clinical trials, research programs and quality improvement efforts. 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, data collection, organizing collected information; records management, expenditure oversight, and communicating with team members on the status of project(s).
Duties and Responsibilities:
Working knowledge of research and applies general analytical skills to administer the logistical implementation of assigned projects, and to identify situations requiring special attention. Utilizing this knowledge, will ensure adherence to research protocols, operating procedures, and all associated internal/external regulations.
Collaborates in the determination of roles & responsibilities of health care team members in the implementation of assigned trials. 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.
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.
Education: Bachelor's degree in nursing or related discipline
Experience: Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Minimum of two years' experience in the specialty and experience in coordinating trials. Additional experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience. Current CPR certification required. Must maintain current licensure and certification during duration of employment. Completion of the JHH credentialing process is required prior to start date.
Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served required.
The individual must demonstrate knowledge of the principles of growth and development over the lifespan and possess the ability to assess data reflective of the patients requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures required. Knowledge of investigational therapies which require special expertise and clinical care management required. Highly effective verbal and written communication skills are required. Must demonstrate knowledge in institutional IRB and safety regulations.
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