We are seeking a Sr. Research Program Coordinator IIfor research conducted within the Jerome L. Greene Sjgren's Center at Johns Hopkins Bayview Medical Center. The Sr. Research Program Coordinator II, working closely with the Center Director and other faculty/staff, will provide project management and leadership over a research portfolio that currently consists of federally funded projects, such as the Sjgren's Team for Accelerating Medicines Partnership (STAMP), privately funded clinical trials, and the Johns Hopkins Sjgren's Center Research Registry, a comprehensive database with respect to individuals diagnosed with Sjgren's Syndrome, related autoimmune diseases, and/or an illness suspicious for Sjgren's.
Specific Duties & Responsibilities
The successful candidate will be responsible for the overall coordination and oversight of multiple research projects and will operate independently, with guidance from the Director.
The Sr. Research Program Coordinator II will be responsible for logistics planning, administrative and scientific protocol implementation, supervision of research staff and trainees, data management, and regulatory compliance.
As part of the study team, the successful candidate will play a key role as a liaison for the Johns Hopkins Sjgren's Center, and will regularly interface with patients, study team members, and external collaborators.
The Sr. Research Program Coordinator II will demonstrate an ability to synergize administrative and scientific activities to drive research and scholarship in this disease whilst providing outstanding clinical care to patients.
Essential Job Functions
Manage research and program efforts of the Jerome L. Greene Sjgren's Center.
Lead the scientific implementation and daily operations of multiple and/or complex research studies.
Track and manage multiple projects and project-related logistics simultaneously.
Develop study protocol and associated procedures to achieve specific research aims and project goals.
Ensure adherence to research protocols and oversee record management for research studies/ projects.
Oversee study recruitment procedures consistent with IRB approved methods.
Identify and triage project challenges to study team members to assure that remedies are quickly implemented, and timelines are maintained.
Assist with IRB applications, manuscript preparation and analyzing data.
Participate in project meetings and contribute to group discussions related to study design, data analysis, and next steps.
Clinical Research Activities
Participate with the Center Director and/or Principal Investigator(s) and other faculty/staff in the overall planning for research.
Responsible for the organization, entry, maintenance and accuracy of patient clinical research data.
Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
Maintain research charts, source documents and other relevant administrative information for each subject.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus. Screen, consent and enroll study participants. Responsible for participants# visits, collection of data, record maintenance, and regulatory documentation.
Comply fully with institutional and external clinical research requisites.
Identify opportunities and participate in efforts to increase public awareness of the Sjgren's Center and its research portfolio.
Develop protocols and associated procedures to achieve specific research aims and project goals per regulatory guidelines.
Develop tools and materials as needed and complete and maintain professional documentation for projects and deliverables.
Maintain regulatory binders per study protocol and document adverse events and protocol deviations in a timely manner.
Prepare and submit progress reports, annual renewal requests, protocol amendments and safety reports as needed per regulatory requirements.
Complete and maintain all training requirements for biohazard material handling and department of transportation (DOT) shipping requirements.
Complete human subjects research training and maintain training compliance required at the regulatory and institutional level.
Assist outside monitors prior to and during study audits.
Assist with quality assurance and regulatory procedures including communications with the IRB, DSMB, and other oversight groups as needed.
Responsible for patient clinical data management and quality control based on protocol requirements and study objectives.
Work closely with study team members to assist in the maintenance of: (1) a research database of patients enrolled in clinical trials, and (2) the Johns Hopkins Sjgren's Center Research Registry, a comprehensive database with respect to individuals diagnosed with Sjgren's Syndrome, related autoimmune diseases, and/or an illness suspicious for Sjgren's.
Maintain and promptly update online Clinical Research Management System (CRMS).
Respond in a timely manner to special projects or queries related to data.
Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry processes.
Coordinate annual progress reports for NIH funded studies.
Support investigators in writing grant submissions, annual reports, abstract submissions, and other reports as needed.
Working with the Center Director, assist with budget activities and expenditures related to research projects and divisional budget analyst.
Bachelor's Degree in related discipline.
Five years related experience.
Proficient in the use of standard software applications, databases, spreadsheets and word processing.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Related Master's preferred.
Special Knowledge, Skills, & Abilities
Adhere to guidelines regarding honest reporting of sensitive and confidential research and participant information.
Understand the importance/impact of data integrity in terms of participants, study results, costs, quality of service and scientific research in general.
Good judgment, tact and sensitivity in regular contact with researchers and collaborators.
Excellent organizational and time management skills.
Excellent interpersonal skills.
Excellent oral and written communication skills.
Excellent attention to detail.
Able to manage multiple and competing priorities.
Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: Min $47,500 - Max $83,300 Annually ($64,400 targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am - 5pm Exempt Status: Exempt Location: Hybrid/Johns Hopkins Bayview Department name: SOM DOM Bay Rheumatology Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: 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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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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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