Research - Laboratory/Non-Laboratory, Staff/Administrative
Under direct supervision of Program Manager and Principal Investigator the Research Program Coordinatorsupports Department of Surgery. Surgery is emergent in nature and therefore the coordinator’s hours need to be flexible according to patient and organ availability. Coordinate 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.
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 moderately complex tracking database/spreadsheet based on study requirements utilizing Excel, Access, or similar software applications.
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.
Utilizing working knowledge of study(s) will participate in meetings to provide operationalupdates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues.
May 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.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on/off campus.
Ensure that case files and accompanying paperwork are organized and current. Other duties as assigned.
Oversee patient recruitment, screening for eligibility, and enroll eligible subjects for participation in research protocols within HPB Division. Explain the protocol in detail and obtain informed consent from potential subjects.
Patient education for Solid Tumor Panel and Microsatellite Instability for clinical testing as part of Precision Medicine Center of Excellence Program
Assist in the development of standard operating procedures and regulatory policy for the Precision Medicine Program.
Preparation, maintenance, and revision of IRB applications, while maintaining continual regulatory compliance.
Weekly scheduling of patient study appointment and labs draws. Provide for the collection, processing, and storage of clinical samples, including blood, tumor, and muscle tissue, from study subjects.
Processing of serological patient samples and isolation of circulating tumor cells including use of ISET Rarecells System.
Collaborate with Hospital and University personnel including inpatient, outpatient, and house staff for the purpose of research implementation, daily operation, and data management of multiple non-interventional trials.
Work close with Research Manager to maintain study expenditure tracking and reporting milestones for financial invoicing.
Conduct site initiation visits for studies for where PI is a Co-investigator. Maintain communication with affiliate main site to ensure timely submissions and adherence to protocol guidelines.Ensures high quality data submission, timely submission of data for study databases.
Responsible for development of tools for study implementation including Precision medicine centralized lab manuals, standardized order sheets, scheduling protocols, and detailed sample processing records.
Act as a liaison for various studies with sponsors, study monitors, patients and their care providers; assist various monitors during study monitor visits and audits.
Work regularly with divisional directors to discuss study updates, streamlining processes, implementation of new protocols, and overall project progress.
Coordinate volunteers and visiting medical students with research faculty mentors to engage research methodology processes, lab techniques, and their clinical applications.
Training volunteers, visiting students, and new hires through clinical shadowing for consent and research related procedures.
Provide backup support for other research staff on other protocols other than primary assignments, as needed
Bachelor’s degree in related field required. Some related experience required. Administrative experience preferred. Additional education may substitute for experience, and additional experience may substitute for education, to the extent permitted by the JHU Equivalency Formula.
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
Sitting in a normal seated position for extended periods of time. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity to manipulate objects with fingers rather than with whole hand or arm, for example, using a keyboard. Ability to move about workspace.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26-$22.35/Hour; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm Exempt Status: Non-Exempt Location: School of Medicine, East Baltimore Campus Department Name: Surgery, Clinical Research Office Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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