Senior Clinical Research Associate - Contract position

About the role

ProTrials is seeking a Contract Senior Clinical Research Associate to join our team. The Contract Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials, ensuring they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Travel may be required up to 65%.

Responsibilities

• Monitor clinical studies of investigational and approved products, 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 progress by reviewing and reporting on 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; 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 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.

Requirements

• 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 with excellent organizational skills, strong interpersonal and communication skills, and strong problem-solving skills.
• Flexibility with changing priorities and 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.