ProTrials Research, Inc. · 11 hours ago
Senior Clinical Research Associate
New York, United States
Full-time
Onsite
Senior LevelProTrials Research, Inc. is a women-owned, WBENC-certified Contract Research Organization committed to advancing clinical research with care, integrity, and excellence. The Senior Clinical Research Associate plays a critical role in monitoring and managing clinical trials, ensuring compliance with protocols and regulatory requirements, while also training site personnel and maintaining communication with study centers.
Biotechnology
Hiring Manager
Chris Busche, MS
Responsibilities
Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
Manage and track the preparation and return of investigational supplies at individual sites
Monitor and document investigational product dispensing, inventory, and reconciliation
Monitor and document laboratory sample storage and shipment
Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
Review data queries and listings, and work with study centers to resolve data discrepancies
Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues
Qualification
Required
RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
Detail-oriented
Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
Flexibility with changing priorities
Ability to efficiently perform and prioritize multiple tasks
Familiarity with the medical and pharmaceutical industries, and related terminology and practices
Extensive knowledge of FDA regulations and their practical implementation
Ability to travel, including by air or by car on short notice
Proficiency in Microsoft Word, Excel, and PowerPoint
Benefits
Full medical, dental, and vision insurance options for you and your family
Flexible PTO
401(k) plan includes a company match
Company
ProTrials Research, Inc.
ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in Los Gatos, CA, with clinical operations personnel located throughout North America and across the world.
Founded in 1996
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Inger Arum
Founder & Co-CEO
Jodi Andrews
Founder & Co-CEO
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