| Job Description: |
Regulatory & Budget Coordination
- Demonstrates comprehensive knowledge of institutional IRB and Western IRB policies, procedures, and standards of conduct.
- Assists the Principal Investigator (PI) in ensuring compliance with all regulatory guidelines for prospective, retrospective, Emergency Use Only, and Humanitarian Device Exemption studies.
- Manages the full IRB lifecycle, including drafting and coordinating research protocols, informed consent forms, and introductory questionnaires for IRB submission.
- Provides ongoing research compliance oversight and supports the PI in meeting regulatory obligations.
- Attend investigator meetings as required and complete all annual, biannual, and triannual mandatory training.
- Submits protocol registration and study results to ClinicalTrials.gov in accordance with institutional and federal requirements.
- Assists PIs in developing project budgets, including calculating personnel and facilities costs. Forecasts expenditures across the project period to prevent overspending or underspending.
- Manages fiscal research accounts and collaborates with financial teams to ensure billing compliance.
- Responsible for daily fiscal operations, including approving research charges, processing participant payments, and verifying that expenditures comply with project guidelines.
- Coordinates with clinical billing staff and prepares/sends invoices to sponsors for participant-related charges and per‑patient enrollment fees.
- Ensures adherence to institutional, federal, state, and sponsor billing and compliance regulations. Completes all required billing and compliance training.
- Conducts daily EPIC reviews of potential research‑related charges and maintains detailed tracking logs of all billable items. Collaborates with departmental fiscal managers to verify appropriate billing.
- Ensures all research‑related charges are reconciled prior to study closure. Verifies that payments originate from the correct sources and that no participant or third‑party payor charges were incorrectly paid with study funds.
- Prepares audit materials—including budgets, billing logs, agreements, protocols, contracts, amendments, and IRB documentation—for internal or external reviews.
- Works with the PI to prepare monthly and annual reports, including required submissions to agencies such as CMS, the Department of Defense, and private sponsors. Keeps the PI informed of project fiscal status.
Research Coordination
- Supports PIs in developing, implementing, and evaluating clinical research activities, recommending process or procedural improvements when needed.
- Oversee participant enrollment and provides study-related clinical support under PI supervision.
- Schedules and coordinates study procedures, including those requiring multidisciplinary collaboration.
- Educates participants and families regarding study expectations and reinforces study-related instructions throughout participation.
- Reviews and interprets medical records, including medications, vital signs, medical and surgical histories, diagnostic test results, operative reports, and clinic notes.
- Access and analyze patient data from HIS, EPIC, LCR, and Data Support Services.
- Collect follow-up data from hospital charts, assessments, and clinical encounters.
- Coordinate follow up appointments in collaboration with patient coordinators and clinic staff.
- Notifies the PI of Serious Adverse Events (SAEs) and facilitates completion of SAE reports for the IRB and study sponsor.
- Tracks disbursements and monitors invoice payments related to study activities.
- Communicate regularly with research participants, families, and referring physicians regarding study status, eligibility criteria, and ongoing participation.
- Monitor and document patient’s daily capacity to provide consent, particularly when consent is initially obtained from a legally authorized representative (LAR).
- Ensure appropriate adherence to inclusion and exclusion criteria when corresponding with referring providers.
Data Management
- Oversee subject enrollment and follow-up activities across assigned research projects.
- Accurately collect, enter, and maintain study data for all participants.
- Review and resolve enrollment concerns with the PI, implementing necessary adjustments based on PI guidance.
- Manage multiple electronic databases and ensure consistent, high-quality data entry.
- Submit monthly patient screening and prescreening reports to required agencies or teams.
- Complete sponsor-requested data clarification forms and resolves data queries promptly.
Performs additional tasks that support study operations, program objectives, or the needs of the PI and
research team.
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| Preferred: |
Master’s degree or higher.
Knowledge of IRB procedures, forms, and the regulatory approval process.
Strong verbal and written communication skills.
Ability to establish and maintain effective working relationships with faculty, staff, patients, and external
partners.
Proficiency in preparing letters, memoranda, and standard business documents in proper format.
Ability to operate general office equipment and standard administrative tools.
Ability to communicate effectively and compassionately with patients and their families.
Adaptability in dynamic, fast‑paced research environments and the ability to contribute to collaborative,
ad‑hoc planning.
Knowledge of topical wound care, wound assessment techniques, and dressing applications.
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