Sr. Research Program Coordinator

Research:

• Assist in finalizing research manuscripts, primarily through reference management activities.
• Develop and maintain cross-project monitoring systems for regulatory and major project milestone deadlines.
• Participate in the development and updating of IRB protocols and FDA INDs.
• Coordinate with faculty and staff at 7 sites that collaborate in the NIH consortium.
• Collaborate with faculty and other collaborators, develop protocols, and ensure protocols are observed for one or more studies.
• Communicate regularly with the Principal Investigator, co-investigators and collaborators regarding the progress of the research and management of problems.
• Apply independent thought to make decisions in collaboration with faculty and PIs within JHU and the NIH ARCH consortium.
• Assist in the development of grant proposals, research manuscripts, preparation and execution of regulatory compliance documents.
• Develop and modify resource materials and study data collection materials including study surveys, recruitment materials.
• Work with the study data manager/biostatistician to develop study databases and reports.
• Participate in other projects and activities as assigned.

Regulatory:

• Develop annual progress reports, oversight of regulatory compliance requirements and other activities identified by faculty or consortium members.
• Track pending updates to protocols for periodic CIR submissions to the IRB.
• Ensure maintenance of regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies.
• Work with study investigators to develop and submit FDA INDs for new studies.
• Assure protocol and study manuals have complete, consistent language throughout, including proper SAE (serious adverse event) reporting requirements, coordinating center requirements, etc.
• Ensure all assigned tasks are conducted in accordance with federal regulations and ICH/GCP.

Administrative:

• Responsible for web-site development for internal and external use.
• Develop resource materials, including a quarterly newsletter.
• Organize and transcribe monthly conference calls and annual working conferences of faculty and advisory members.

• Bachelor’s degree in a related discipline required.
• Three (3) years 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.

Special Knowledge, Skills, and Abilities:

• Ability to work independently.
• Ability to interact with faculty and staff on research teams, in clinical programs, and with educational outreach initiative to strategize about their communication needs.
• Excellent oral communication skills to deal effectively within and outside the department.
• Excellent written communications skills in a variety of forms, print material, website content, speeches, and publicity materials.
• Excellent organizational skills to work effectively in an environment that requires balancing multiple assignments.
• Ability to interact effectively with individuals at all levels and from diverse cultures.