Clinical Research Assistant: Trials Support & Coordination

Pinnacle Clinical Research- A Summit Solution; Dallas (TX); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

401k

Medical, dental, vision insurance

Long term disability

Short term disability

FSA

Life insurance

3 weeks of paid time off

14 paid company holidays

Scrub voucher

Job summary

Pinnacle Clinical Research- A Summit Solution in Dallas seeks a Clinical Research Assistant to support the coordination of clinical trials. You will assist with study documents, regulatory submissions, and CTMS updates, while maintaining subject confidentiality and complying with FDA, ICH GCP, HIPAA, and IRB requirements.

You will interact with physicians, nurses, and sponsors, coordinate assessments and visits, and help recruit subjects while ensuring accurate reporting and documentation.

Qualifications

• High school diploma or GED or 2–4 years related experience or equivalent
• Clinical research certification preferred
• Ability to demonstrate competence in oral and written communication
• Must be organized, attentive to detail, and possess a professional demeanor
• Must be flexible with changing priorities and communicate in a diplomatic manner
• Medical knowledge including medical terminology
• Ability to read/interpret documents and write routine reports
• Proficiency with Microsoft Office and web-based applications

Responsibilities

• Assist with creation and completion of study documents and new study preparation
• Assist with regulatory submissions and maintain regulatory files
• Act as secondary liaison with sponsors
• Prepare for study monitor visits as directed
• Create reports as requested
• Assist with subject assessments including adverse events, TA handling, scheduling, records review, and health assessments
• Support subject screening and recruitment
• Update CTMS as directed
• Coordinate multiple projects with competing priorities and deadlines
• Interact with physicians, nurses, staff, sponsors, and trial patients

Skills

Oral and written communication

Organization

Attention to detail

Flexibility

Medical terminology

Interpersonal communication

Public speaking

Education

High school diploma or GED

Tools

Microsoft Office

Word

Excel

Web-based enterprise solutions

Electronic Case Report Form systems

Job description

Pinnacle Clinical Research- A Summit Solution in Dallas seeks a Clinical Research Assistant to support the coordination of clinical trials. You will assist with study documents, regulatory submissions, and CTMS updates, while maintaining subject confidentiality and complying with FDA, ICH GCP, HIPAA, and IRB requirements.

You will interact with physicians, nurses, and sponsors, coordinate assessments and visits, and help recruit subjects while ensuring accurate reporting and documentation.