What are the responsibilities and job description for the Senior Clinical Research Associate position at DR VINCE CLINICAL RESEARCH PA?
POSITION SUMMARY: The Senior Clinical Research Associate (Senior CRA / Sr. CRA) conducts clinical trial monitoring activities to ensure assigned clinical trials are conducted and documented in accordance with applicable International Council for Harmonisation and Good Clinical Practice (ICH-GCP) guidelines, study protocols, and regulatory requirements
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.
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
- Proficiency in MS Word, Excel and PowerPoint programs
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Work Location: Hybrid remote in Overland Park, KS 66212