UNIV - Regulatory and Grant Administration Coordinator - Department of Dermatology

Job Duties

• Start Up Coordination (30%):
  • Conduct and coordinate study feasibility assessments.
  • Facilitate Site Qualification Visits (SQVs) and support sponsor interactions.
  • Utilize SPARC to coordinate research-related services and resources required for clinical trials, including study set-up, ancillary service requests, departmental approvals, study calendars, budgeting support, and activation activities to ensure operational readiness and institutional compliance.
  • Coordinate with ancillary hospital services and support departments to ensure all required study-related processes, approvals, and operational workflows are established during study start-up and prior to activation.
  • Submit and maintain Protocol Reimbursement Analysis (PRA) requests and amendments.
  • Complete EPIC research build requests and order set development in collaboration with clinical and operational teams.
• Regulatory Coordination (30%):
  • Prepare and submit initial Institutional Review Board (IRB) applications.
  • Complete and track pre-activation regulatory and study start-up documentation.
  • Manage electronic regulatory (eReg) systems, including: pushing studies into eReg platforms and adding and maintaining study personnel access and documentation.
  • Prepare and submit continuing reviews, reportable events, amendments, and other regulatory updates as required.
  • Maintain accurate regulatory files and ensure ongoing compliance with institutional, sponsor, GCP, and federal requirements.
• Grant Administration (25%):
  • Assist with grant proposal preparation and submission activities.
  • Develop, prepare, and coordinate grant budgets and budget justifications in collaboration with investigators and departmental leadership, ensuring compliance with sponsor and institutional requirements.
  • Prepare and submit grant applications, modifications, and related documentation through Cayuse.
  • Coordinate administrative components of sponsored research submissions.
  • Track grant deadlines, approvals, and compliance requirements to ensure timely submission and adherence to sponsor and institutional policies.
  • Collaborate with investigators, department administrators, and institutional offices to facilitate timely grant submissions and post-award documentation.
  • Assist with budget revisions, re-budgeting requests, no-cost extensions, and other pre-award administrative activities as needed.
  • Support post-award documentation, reporting, and administrative processes related to sponsored projects.
  • Register and maintain applicable studies in ClinicalTrials.gov, including initial registration, record updates, and results reporting as required.
  • Prepare and maintain supporting documentation required for grant applications, progress reports, regulatory compliance, and sponsor submissions.
  • Coordinate collection and submission of investigator biosketches, other support documents, current and pending support information, and related proposal materials.
  • Complete other grant administration and research support activities as assigned.
• Study Coordination and Compliance Support (15%):
  • Serve as a liaison between investigators, sponsors, institutional offices, and regulatory bodies.
  • Monitor study timelines to ensure timely completion of regulatory and administrative milestones.
  • Support audit and inspection readiness activities.
  • Maintain study records and documentation in accordance with institutional policies and regulatory requirements.

Minimum Requirements

A bachelor's degree and three years of relevant program experience.

Physical Requirements

(Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift)

• Ability to perform job functions in an upright position. (Frequent)
• Ability to perform job functions in a seated position. (Frequent)
• Ability to perform job functions while walking/mobile. (Frequent)
• Ability to work indoors. (Continuous)
• Ability to work outdoors in all weather and temperature extremes. (Infrequent)
• Ability to work in confined/cramped spaces. (Infrequent)
• Ability to perform job functions from kneeling positions. (Infrequent)
• Ability to squat and perform job functions. (Infrequent)
• Ability to perform 'pinching' operations. (Infrequent)
• Ability to fully use both hands/arms. (Frequent)
• Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent)
• Ability to reach in all directions. (Frequent)
• Possess good finger dexterity. (Continuous)
• Ability to maintain tactile sensory functions. (Continuous)
• Ability to lift and carry 15 lbs., unassisted. (Infrequent)
• Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent)
• Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent)
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous)
• Ability to see and recognize objects close at hand. (Frequent)
• Ability to see and recognize objects at a distance. (Frequent)
• Ability to determine distance/relationship between objects; depth perception. (Frequent)
• Good peripheral vision capabilities. (Continuous)
• Ability to maintain hearing acuity, with correction. (Continuous)
• Ability to perform gross motor functions with frequent fine motor movements. (Frequent)