Study Coordinator -258461
Company: Medix™ Agency
- Location: Overland Park, United States
- Seniority: Mid level
- Employment type: Full-time
- Posted: 14 days ago
- Offer language: English
Job description
We are seeking an experienced, detail-oriented Clinical Research Coordinator to support a full-time, dedicated pharmaceutical asthma study in the Overland Park, KS area. Sponsored by a leading global pharmaceutical sponsor, this role provides focused, single-protocol project support covering full-cycle clinical trial coordination, regulatory maintenance, patient engagement, and hands-on clinical procedures. It is a project based temporary contracted role.
Responsibilities
- Recruitment & Patient Outreach: Execute recruitment strategies including chart reviews, phone pre-screenings, media referral processing, community outreach, and physician referral networking.
- Patient Consenting & Visit Prep: Conduct the full informed consent process with study participants and handle all visit preparations according to strict protocol guidelines.
- Clinical Procedures & Lab Processing: Perform protocol-required spirometry (non-invasive breathing tests) and handle specimen/lab processing (Note: position focuses on lab processing; no phlebotomy or blood draws required).
- Regulatory Compliance: Manage essential regulatory documentation, including Investigator Site File maintenance, IRB submissions, and ongoing regulatory submittals.
- Data Entry & Administrative Workflows: Complete timely clinical data entry in Electronic Data Capture systems (Veeva EDC), oversee participant e-Diary compliance, manage source documentation, and execute scheduling and appointment reminders (RealTime).
Required Qualifications
- 2+ years of experience as a Clinical Research Coordinator or Study Coordinator supporting sponsor-funded, pharmaceutical interventional trials.
- Regulatory Expertise: Hands-on experience managing ISF documentation and submitting to IRBs.
- Clinical/Lab Skills: Demonstrated experience with lab specimen processing and spirometry testing.
- Software Proficiency: Hands-on experience navigating Veeva EDC and RealTime scheduling/trial management software.
- Regulatory Knowledge: Deep understanding of FDA regulations, ICH guidelines, and Good Clinical Practice.
- Lab Processing experience is needed!
Preferred Qualifications
- Prior experience coordinating Asthma, Respiratory, or Immunology clinical trials.
Schedule & Logistics
- Role Type: Full-time, temporary/project-based contract (40 hours per week).
- Schedule: Standard day shift, Monday through Friday, 8:00 AM – 5:00 PM (Strictly no evenings or weekends).
- May be eligible to enroll in benefits but it must be mentioned before starting working.
