Research - Laboratory/Non-Laboratory, Staff/Administrative
The Sr. Research Program Coordinator will assist the research team with the conduct of pharmaceutical sponsored clinical trials, long-term NIH-funded or other investigator-initiated research protocols examining the treatment and progression of disease in adults with HIV, hepatitis, and other gastrointestinal disorders. The research will take place on the East Baltimore Campus.
Develops recruitment and retention strategies for difficult and vulnerable populations. Identifies areas for improvement in clinical research infrastructure and addresses suggestions in collaboration with teammates and the Research Nurse Manager. Manages competing and shifting priorities effectively. Coordinates and leads site initiation visits for studies where Hopkins is a participating site in a multisite study, is the single site for an investigator-initiated study, or is the Coordinating Center and our Pl is the Lead or Protocol Chair. Maintains communication with affiliate institutions to ensure high quality of data, timely submission of data, and adherence to guidelines. Serves as administrative, quality assurance, and as a regulatory contact for complex multi-center clinical trials for participating sites.
Will revise existing forms as needed to reflect revisions in clinical trial audit procedures and for protocol amendments. Prepares audit schedules, monitoring visits and inspections at participating institutions. Completes minimum requirement for continuing education units for professional growth and development. Maintains good working knowledge of all assigned protocols and reporting requirements. Transmits and distributes protocol information. Responsible for submission, verification, maintenance of protocol specific information on clinicaltrials.gov, as appropriate. Assists with the maintenance of regulatory binder for each assigned protocol. 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.
May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol- specific data collection forms with assistance. Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. 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 can be used by the physician in treatment planning for individual patients, presentations and publication.
Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and registry requirements. Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data. Prepares for and participates in monitoring and audits of studies.
Bachelor’s degree in a related field required.
Three (3) years of related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) may substitute for one year of experience.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.
Excellent time management skills, organizational skills, and attention to detail. Excellent oral and written communication skills, Ability to follow multiple, detailed directions of various protocols and adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Understanding of the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general. Due to regular contact with physicians and other health care personnel (and occasionally patients), the use of good judgment, tact, and sensitivity is strongly desired.
Ability to stand, walk or sit for an extended period of time. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard. Communication skills using the spoken word. Ability to see within normal parameters. Ability to hear within normal range. Possible exposure to communicable diseases. This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Special Knowledge, Skills, and Abilities:
Medical terminology and basic computer skills are required.
Experience using IBM compatible PC and office suite software is required.
Bio-specimen processing skills are required.
Certification in appropriate skill groups must be obtained during introductory period.
Knows the formal and informal departmental and divisional goals, standards, policies and procedures which may include some familiarity of other departments within the school/division.
Is sensitive to the interrelationship of both people and functions within the department/division.
Carries out duties and responsibilities with limited supervision. Reports to the Senior Research Manager.
With the assistance of the Research Nurse Manager, makes decisions and establishes work priorities on procedure and strategic-oriented operations.
Classified title: Sr. Research Program Coordinator
Working title: Sr. Research Program Coordinator
Role/Level/Range: ACRP 37.5/E/03/MB
Starting Salary Range: $38,920.08 - $53,517.60 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk - Casually, some evenings and weekend may be required depending on study design.
Location: SOM Campus – Baltimore, MD
Department name:10002794-SOM DOM Bay Infectious Disease
Personnel area (School): SOM – School of Medicine
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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