Senior Clinical Research Assoc

DR VINCE CLINICAL RESEARCH PA

Overland Park, KS Job Details 19 hours ago Qualifications Record keeping Report writing Clinical compliance checks Research ethical considerations Regulatory compliance Word embeddings Clinical audit and monitoring ICH guidelines Research compliance clinical trial records management Clinical trial standard operating procedures Clinical trial patient safety management Productivity software Clinical quality assurance standards 1 year Senior level Standard operating procedures (SOPs) Communication skills Project stakeholder communication Full Job Description

JOB TITLE

Senior Clinical Research Associate

REPORTS TO

Director, Clinical Trial Services

DIRECT REPORTS

Not Applicable

POSITION SUMMARY

The Senior Clinical Research Associate 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. 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