Job Description

Senior Clinical Research Associate, Phase 1 Oncology

Direct Hire Full-Time Role

Salary Range: $115,000 - $140,000 per year

Location: Remote Role - EST (65% Travel)

Job Summary:

As a Senior Clinical Research Associate, you will be crucial in successfully monitoring and managing clinical trials. You will ensure clinical trials are conducted, recorded, and reported following the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. You may be required to travel for up to 65% of the role.

Duties and Responsibilities:

• Monitor clinical studies of investigational and approved products determined to satisfy a medical need and offer a commercial benefit, including qualification, initiation, interim, and close-out site visits.
• Manage and train site personnel in the 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, 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.

Requirements and Qualifications:

• Phase 1 Oncology experience
• RN, Bachelors and/or an advanced degree in biological sciences or a 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
• Able 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
• Able to travel, including by air or by car, on short notice
• Computer proficiency in Microsoft Word, Excel, and PowerPoint

Desired Skills and Experience

CRA, Phase 1 Oncology, FDA, Microsoft Office, travel

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