What are the responsibilities and job description for the Clinical Research Associate / Clinical Monitor (CRA) position at Dr. Vince Clinical Research?
POSITION SUMMARY: The Clinical Research Associate / Clinical Monitor (CRA), conducts clinical trial monitoring activities to ensure that assigned clinical trials are conducted and documented properly in accordance with current and applicable International Conference of Harmonization and Good Clinical Practice (ICH/GCP) Guidelines.
KEY RESPONSIBILITIES:
- Monitor and verify that the rights and well-being of human subjects are protected
- Verify that the reported clinical trial data are accurate, complete and verifiable from source documents.
- Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment(s), clinical monitoring SOPs, clinical monitoring plan (CMP), ICH/GCP Guidelines and applicable regulatory requirements.
- Maintain primary line of communication between the sponsor, investigator and DVCR staff.
- Perform applicable Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Close-out Visits (COV) as per DVCR Clinical Monitoring SOP and project specific CMP.
- Complete and deliver applicable confirmation letters, monitoring reports and follow-up letters as per DVCR Clinical Monitoring SOP and project specific CMP.
- Other project specific duties as assigned or outlined in the CMP.
- Expected travel (40%-60%)
REQUIRED QUALIFICATIONS:
- At least 5 years of experience as a Clinical Research Associate / Clinical Monitor
- At least 1 year of experience in early clinical development (Phase-1) as a Clinical Research Associate / Clinical Monitor
PREFERRED QUALIFICATIONS:
- At least 7 years of clinical research experience or equivalent healthcare experience
- Possess exceptional attention to detail and the ability to keep detailed and accurate records
- Strong written and verbal communication skills
- Advanced organizational and planning skills
- Local to the Kansas City area
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Paid time off
- Parental leave
- Referral program
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Work Location: In person