Clinical Research Assistant — Trials Support & Coordination

Pinnacle Clinical Research- A Summit Solution; Houston (TX); On-site; USD 42,000 - 65,000; Full time

Benefits offered by this job

401k

Medical, dental, vision, disability, F

3 weeks of paid time off

14 paid holidays

Scrub uniform voucher

Job summary

Pinnacle Clinical Research- A Summit Solution is seeking an organized clinical research support professional to assist the coordinator and investigator with study activities. You will help prepare study documents, manage regulatory files, and coordinate with sponsors, sites, and monitors in a confidential, compliant environment.

Responsibilities include assisting with subject screening, data entry in CTMS and reports, and ensuring adherence to FDA, ICH-GCP, HIPAA, and IRB requirements.

Qualifications

• High school diploma or GED; 2–4 years related experience preferred.
• Clinical research certification preferred.
• Strong oral and written communication abilities.
• Organized, detail-oriented, professional demeanor.
• Familiar with CTMS and MS Office tools.

Responsibilities

• Assist with creation and completion of study documents and prep.
• Assist regulatory submissions and maintain regulatory files.
• Act as secondary liaison with sponsors.
• Prepare for study monitor visits as directed.
• Create reports as requested.
• Complete study assessments including vitals and screening.
• Assist with subject screening and recruitment.
• Update CTMS as directed.
• Coordinate multiple projects with competing deadlines.
• Interact with physicians, nurses, staff, sponsors and lab personnel.

Skills

Communication

Detail oriented

Organizational skills

Medical terminology

Reading/safety docs

Education

High school diploma or GED

Clinical research certification preferred

Tools

CTMS

Microsoft Word

Microsoft Excel

Internet Explorer

Google Chrome

Mozilla Firefox

Job description

Pinnacle Clinical Research- A Summit Solution is seeking an organized clinical research support professional to assist the coordinator and investigator with study activities. You will help prepare study documents, manage regulatory files, and coordinate with sponsors, sites, and monitors in a confidential, compliant environment.

Responsibilities include assisting with subject screening, data entry in CTMS and reports, and ensuring adherence to FDA, ICH-GCP, HIPAA, and IRB requirements.