Research Study Coordinator - 260419
Company: Medix™ Agency
- Location: United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Job Title: Remote Study Coordinator
Schedule: Full-Time, Monday – Friday (Must work Mountain Time hours)
Location: 100% Remote (Non-patient-facing)
Responsibilities
- Plan, track, and operationalize interventional clinical trials across startup, interim, and closeout phases, updating clinical teams on protocol amendments, visit windows, and dose modifications.
- Partner directly with Physician Principal Investigators (PIs), study sponsors, and cross-functional research teams, representing the site during sponsor calls, study meetings, and monitoring visits.
- Design, maintain, and update study-specific source documents, checklists, clinic workflow guides, and standard operating tools in response to protocol modifications.
- Facilitate Interim Monitoring Visits (IMVs), review and respond to CRA follow-up letters, assist in data query resolution, and support audit preparation (including sponsor and FDA inspections).
- Assist in training, onboarding, and mentoring new Study Coordinators and Data Coordinators on study operations and clinical compliance standards.
Requirements
- Minimum of 3+ years of clinical research experience coordinating complex interventional trials.
- At least 1+ year of oncology clinical research experience.
- Associate degree required; Bachelor’s degree preferred.
- Ability to work full-time (Monday–Friday) during core Mountain Time (MT) working hours in a 100% remote, non-patient-facing capacity.
- Demonstrated professional communication skills and working knowledge of GCP/SOP standards for handling protocol amendments, data queries, and sponsor communications.
