Clinical Research Assistant — 401k, PTO & Impact

ADP, Inc.; Dallas (TX); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

401k

Medical, dental, vision, long term &短短

3 weeks of paid time off

14 paid company holidays

Scrub voucher (specific positions)

And more!

Job summary

Summit Clinical Research Solutions in Dallas, TX is seeking a Clinical Research Assistant to support the Clinical Research Coordinator and principal investigator in administering clinical trial activities, ensuring confidentiality and adherence to FDA, ICH GCP, HIPAA, IRB, and sponsor requirements.

Responsibilities include creating study documents, regulatory submissions, liaising with sponsors, preparing for monitor visits, and entering data into CTMS, while coordinating multiple priorities

Qualifications

• Must have strong communication skills, both oral and written.
• Organizational skills with attention to detail and adaptability.
• Basic knowledge of FDA, ICH GCP, HIPAA, IRB guidelines.
• Experience with CTMS and EDC systems is preferred.

Responsibilities

• Assist with study document creation and new study prep.
• Support regulatory submissions and keep files updated.
• Serve as a secondary sponsor liaison.
• Prepare for monitor visits and create reports.
• Enter data and coordinate multiple projects per protocol.
• Interact with study team and patients as needed.

Skills

Oral and written communication

Organized and detail-oriented

Regulatory knowledge

Microsoft Office

CTMS familiarity

Medical terminology

Education

High school diploma or GED

2–4 years related experience

Tools

Microsoft Word

Microsoft Excel

Internet Explorer

Google Chrome

Electronic Case Report Form systems

Job description

Summit Clinical Research Solutions in Dallas, TX is seeking a Clinical Research Assistant to support the Clinical Research Coordinator and principal investigator in administering clinical trial activities, ensuring confidentiality and adherence to FDA, ICH GCP, HIPAA, IRB, and sponsor requirements.

Responsibilities include creating study documents, regulatory submissions, liaising with sponsors, preparing for monitor visits, and entering data into CTMS, while coordinating multiple priorities