Sr. Research Program Coordinator II

We are seeking a Sr. Research Program Coordinator II for 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

Project Management

• 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.

Regulatory Compliance

• 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.

Data Management

• Responsible for