The Department of Radiology seeks a Senior Research Program Coordinator who will be responsible for the Design, Creation, and Management of IR Studies Databases (RedCap, Access, etc...). They will oversee the coordination and implementation of new research protocols and facilitate administrative tasks. As well, they will oversee the day-to-day activities of multiple clinical studies that require a high level of knowledge, coordination, and data abstraction. This individual will assist in study design and contribute to standard operating procedure development and will assist in coordinating efforts between lab members of this diverse and dynamic lab (i.e. physicians, post-docs, medical students, undergraduates, etc.)
The Coordinator will serve as a close link and facilitator between the various members of the research teams (investigators within the Division and across Divisions/ Departments). This position involves frequent contact with researchers, research staff members, and study participants.
Specific Duties & Responsibilities:
Responsible for establishingearly lines of communication with the clinical teams as they are selected and prepared for activation.
Will coordinate the day-to-day support of a clinical research group.
Will communicate with staff and research subjects to carry out research studies.
Will prepare and inform the detailing of the availability of critical resources necessary to succeed atenrollment and protocol performance once the trial begins.
Will participate in clinical trial start-up meetings. Will evaluate the feasibility of the research protocol, detects, and assists in solving logistical & technical problems as necessary.
Will meet regularly with Senior Research Nurse and Principal investigator to review data accuracy and overall study progress. Will participate in all mandatory meetings to develop increasing knowledge of assigned clinical trial registry requirements.
Will manage all aspects of IRB submissions: preparing and submitting continuing review requests, making changes in research amendments, and creating adverse event reports with clinical input according to IRB, DSMB, and sponsor requirements. Will follow-up with IRB specialist regarding issues & questions from the review committee and formulate responses to the issues. Will navigate the online system to correct and respond to issues. Will ensure protocols and consent forms are complete and have consistent language throughout.
Will maintain good working knowledge of all assigned study protocols and reporting requirements. Will transmit and distribute protocol information. Keeps a regulatory binder with the appropriate support documentation for each assigned protocol. Updates and maintains current protocol and research changes. Will adhere to all protocol requirements to ensure the validity of clinical outcomes.
Will implement research protocols by recruiting and enrolling eligible patients into studies.
Will contact the participants to conduct telephone screening and schedule visits.
Will assist the PI with informed consent.
Will implement local solutions to keep the recruitment goal on track for trial completion.
Will follow up with the participants for any adverse events and maintain documentation on all subjects.
Will schedule each participant and ensures compliance is met. Will have the ability to anticipate and adapt effectively to changes in complex research studies.
Will manage study audits and monitor visits.
Will collect research data and manages study databases. Will enter data, control data quality, and maintain research & data integrity in the study databases, billing databases, and the electronic medical record where appropriate.
Will prepare and display data and present progress to investigators, funding agencies and necessary compliance authorities as requested / as required by protocols.
Will provide support for quality assurance monitors and Research Program Managers in all facets of work related to communications with and management of the clinical team
Will individually mentor new coordinators and study team staff.
Will perform other duties assigned by the PI or division leadership for the benefit of the IR research program.
Minimum Qualifications (Mandatory):
Bachelor's degree in related discipline.
Three (3) years of experience in delivering effective project management solutions.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Special Knowledge, Skills & Abilities:
Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
Outstanding organizational skills required. Excellent attention to detail skills required.
Must have excellent time management skills.
Ability to understand and implement support for clinical trials.
Ability to manage multiple projects at once and effectively prioritize each.
Requires outstanding verbal communication and interpersonal skills.
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other healthcare personnel, and occasionally, patients requires good judgment, tact, and sensitivity.
Excellent leadership skills to negotiate and work collaboratively.
Service-oriented with excellent verbal and written communication and organization skills.
Knowledge of formal project management methodologies.
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.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920 - $53,520 annually (commensurate with experience) Employee group: Full Time Schedule: M-F, 8:30AM - 5:00PM Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Rad Interventional Radiology 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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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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