ProTrials Research,

ProTrials Research, Inc. | Full Service CRO | CRO Services Woman Owned CRO, full service clinical research organization for medical device & diagnostics, and pharmaceutical & biotechnology industries. ProTrials provides clinical operations professional...

Professional Services

Industrials

51-250 (180)

Founded 1996

6 open positions

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Senior Clinical Research Associate

3 weeks, 3 days ago

Not Available

Full-time

Senior

Operations Specialist

Operations

Apply Now

ProTrials Research,

Professional Services

51-250

Founded 1996

View All Jobs 6

Description

Conduct qualification, initiation, interim, and close-out site visits for clinical studies.
Train and manage site personnel on therapeutic areas, protocols, source documentation, and case report forms.
Track investigational supplies, product dispensing, inventory, and reconciliation.
Monitor laboratory sample storage and shipment.
Review and report enrollment, site status, monitoring visits, protocol deviations, serious adverse events, and laboratory abnormalities.
Verify source data and case report forms for accuracy, completeness, and integrity, and resolve data issues.
Review data queries and listings and work with study centers to resolve discrepancies.
Review regulatory documentation and support study centers with regulatory issues.
Maintain complete and accurate study files and ensure required documentation is present.
Provide support and solutions to project team members, including CRA I and CRA II staff.

Requirements

RN, bachelor’s or advanced degree in biological sciences or a related field, or an equivalent combination of education, training, and relevant experience.
Previous CRA experience demonstrating career growth in the CRA role.
Extensive knowledge of FDA regulations and their practical implementation.
Familiarity with the medical and pharmaceutical industries, terminology, and practices.
Strong attention to detail, organizational, interpersonal, communication, and problem-solving skills.
Ability to adapt to changing priorities and efficiently prioritize multiple tasks.
Ability to travel by air or car, including on short notice; travel may reach 65%.
Proficiency in Microsoft Word, Excel, and PowerPoint.

Benefits

Medical, dental, and vision insurance for employees and families.
Flexible paid time off.
401(k) plan with company match.
Professional growth, skills development, and career advancement opportunities.
Collaborative and supportive work environment.

Interested in this position?

Apply directly on the company website

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