Clinical Research Assistant - Regulatory & Study Coordination

Pinnacle Clinical Research- A Summit Solution; Corpus Christi (TX); In loco; USD 42.000 - 54.000; Tempo pieno

Vantaggi offerti da questo lavoro

401k

Medical, dental, vision, long term and

short term disability

FSA

Life insurance

3 weeks paid time off

14 paid company holidays

Scrub voucher

Descrizione del lavoro

Summit Clinical Research Solutions in Corpus Christi, TX seeks a detail-oriented assistant to support the Clinical Research Coordinator and principal investigator in day-to-day study activities, document handling, and compliance with FDA, ICH GCP, and HIPAA protocols.

You will help prepare study materials, coordinate visits, manage regulatory files, assist with subject screening, and maintain CTMS records while communicating professionally with sponsors, sites, and staff.

Competenze

• Must have strong oral and written communication skills.
• Organized, detail-oriented with professional demeanor.
• Familiar with clinical trial regulations (FDA, ICH GCP, HIPAA) and SOPs.

Mansioni

• Assist with creation and completion of study documents and new study preparation.
• Assist with regulatory submissions and maintain regulatory files.
• Acts as secondary liaison with sponsors.
• Assist with preparation for study monitor visits.
• Create reports as requested.
• Assist with subject screening and recruitment.
• Update CTMS as directed.
• Coordinate multiple projects with competing priorities and deadlines.
• Interact with physicians, nurses, admin staff, sponsors, lab personnel, and patients.

Conoscenze

Oral communication

Written communication

Organizational skills

Attention to detail

Medical terminology

Professional demeanor

Formazione

High school diploma or GED

Clinical research certification preferred

Strumenti

Microsoft Office (Word/Excel)

CTMS

Electronic Case Report Form systems

Web-based enterprise solutions

Web browsers (IE/Chrome/Firefox)

Descrizione del lavoro

Summit Clinical Research Solutions in Corpus Christi, TX seeks a detail-oriented assistant to support the Clinical Research Coordinator and principal investigator in day-to-day study activities, document handling, and compliance with FDA, ICH GCP, and HIPAA protocols.

You will help prepare study materials, coordinate visits, manage regulatory files, assist with subject screening, and maintain CTMS records while communicating professionally with sponsors, sites, and staff.