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Inside Higher Ed · 2 days ago

Sr. Research Program Coordinator II

Baltimore, MD

Full-time

Onsite

Mid, Senior Level

$48K/yr - $84K/yr

5+ years exp

Inside Higher Ed is seeking a Senior Research Program Coordinator II to coordinate and support the research efforts of the JH ICU Clinical Trials Group. The role involves ensuring timely submissions to the IRB, analyzing data, maintaining study documents, and providing project support to faculty.

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Responsibilities

Work closely with the Principal Investigators on studies to ensure timely, accurate submission to the IRB of studies applications

Assure study protocols have complete, consistent language throughout. Follow up the status and identify bottlenecks in the approval processes

Obtain all required documents for study submissions to the IRB

Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process

Analyze data and contribute to writing draft or sections of manuscripts

Develop and maintain study documents such as laboratory manuals

Internally monitor regulatory files and study data to assess compliance, data quality, and accuracy

Complete IRB amendment submissions and ensure documentation of training

Attend study start up meetings for all studies, and present data at meetings as needed

Produce and maintain a regulatory binder prior to study starting with all required documents

Work closely with Principal Investigators to ensure all documents are reviewed, approved and correct prior and during the study

Ensure all documents are being collected in a timely manner and all regulatory binders are up to date

Assist with study monitoring/auditing requirements

Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data

Conduct training sessions for lower level program coordinators working at other locations within multi-centered clinical trial

Develop standard operating procedures for regulatory submissions as needed

Maintain a continued high level of expertise in institutional databases including REDCap, OpenSpecimen, EPIC, Oncore, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program

Review and analyze studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications

Complete minimum requirements for continuing education units. Maintain up to date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Teaches staff about regulatory aspects

Updates faculty on regulatory study status

Provide complex project support to the faculty including assistance with grant application and progress report, translational research protocols and important correspondence, and project management. This person will deal regularly with highly sensitive, privileged and confidential subject matter

Edit presentations

Coordinate and manage communications work with internal and external entities

Oversight of study budgets and contracts processing through ORA to assure execution and completion in a timely manner

If needed and as time permits, support data collection and entry related to research studies

If needed and as time permits, help with participant enrollment in research studies

If needed and as time permits, transport biospecimens to lab for processing