This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate - Contract Position based in United States. This contract opportunity is designed for an experienced clinical research professional who wants to play a key role in the successful execution of clinical trials. You will monitor studies involving investigational and approved products while ensuring compliance with protocols, SOPs, ICH GCP, and applicable regulatory requirements. The role covers the full site lifecycle, from qualification and initiation through interim monitoring and close-out activities. You will work closely with investigators, coordinators, study teams, and other stakeholders to maintain data quality, resolve issues, and support trial progress. The position also offers an opportunity to mentor less experienced CRAs and contribute practical solutions to complex study challenges. Frequent travel is an important component of the role, with travel requirements of up to 65%. Accountabilities: - Conduct qualification, initiation, interim, and close-out site visits for clinical studies involving investigational and approved products. - Monitor clinical trials to ensure studies are conducted, documented, and reported in accordance with protocols, SOPs, ICH GCP, and applicable regulatory requirements. - Train and support site personnel on therapeutic areas, protocol requirements, source documentation, and case report form completion. - Manage and track investigational supplies, including preparation, shipment, dispensing, inventory, reconciliation, and return. - Monitor laboratory sample storage and shipment activities and ensure appropriate documentation. - Track and report site enrollment and termination updates, monitoring activities, protocol deviations, serious adverse events, and laboratory abnormalities. - Review source data and case report forms for accuracy, completeness, consistency, and data integrity, identifying and resolving ongoing issues. - Review data queries and listings and collaborate with study sites to resolve discrepancies efficiently.
- Review regulatory documentation for accuracy and completeness and provide support when sites encounter regulatory issues. - Maintain complete and accurate study files and conduct regular reviews to ensure required documentation is present. - Maintain consistent and timely communication with investigators, coordinators, study centers, project teams, and other clinical trial stakeholders. - Serve as a resource to project team members and provide guidance and practical solutions to CRA I and CRA II colleagues. Requirements: - RN, bachelor's degree, or advanced degree in biological sciences or a related field, or an equivalent combination of relevant education, training, and experience. - Previous CRA experience demonstrating progressive career growth and increasing responsibility within clinical research. - Strong knowledge of clinical trial monitoring practices and the medical and pharmaceutical industries, including relevant terminology and processes. - Extensive knowledge of FDA regulations and their practical application in clinical research. - Strong understanding of protocol compliance, ICH GCP, SOPs, data integrity, and regulatory documentation. - Excellent attention to detail with strong organizational, interpersonal, communication, and problem-solving skills. - Ability to manage multiple priorities efficiently and adapt to changing study requirements. - Strong ability to identify issues, investigate discrepancies, and develop practical solutions. - Ability to build effective working relationships with investigators, site personnel, clients, and cross-functional project teams. - Willingness and ability to travel by air or car on short notice, with travel requirements of up to 65%. - Proficiency in Microsoft Word, Excel, and PowerPoint.
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