Senior Clinical Research Assoc

Priority Dispatch Corp.; Olathe (KS); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

Priority Dispatch Corp. seeks a Senior Clinical Research Associate to monitor clinical trials and ensure activity is conducted and documented in accordance with ICH/GCP guidelines and DVCR SOPs.

You will verify patient rights, data integrity, and compliance across sites, conduct PSV/SIV/IMV/COV visits, and prepare monitoring reports and correspondence per CMP. Strong communication and meticulous record-keeping are essential.

Qualifications

• At least 5 years of experience as a Clinical Research Associate or Clinical Monitor.
• At least 1 year of experience in early clinical development (Phase-1) as a CRA/Monitor.
• Strong attention to detail and the ability to keep detailed and accurate records.
• Excellent written and verbal communication skills.

Responsabilités

• 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.

Connaissances

Attention to detail

Written and verbal communication

Organizational and planning skills

Outils

MS Word

Excel

PowerPoint

Description du poste

JOB DetailsJob Location: 7401 W 91st St - Overland Park, KS 66212JOB 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.

QualificationsREQUIRED 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