Senior Clinical Research Associate
New
J
JobgetherClinical research
Based in United StatesContractSenior
Salary not disclosed
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Job Details
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Have an RN, bachelor's degree, or advanced degree in biological sciences or a related field, or an equivalent combination of relevant education, training, and experience.
- Bring previous CRA experience demonstrating progressive career growth and increasing responsibility within clinical research.
- Have strong knowledge of clinical trial monitoring practices and the medical and pharmaceutical industries.
- Have extensive knowledge of FDA regulations and their practical application in clinical research.
- Understand protocol compliance, ICH GCP, SOPs, data integrity, and regulatory documentation.
- Demonstrate attention to detail, organizational, interpersonal, communication, and problem-solving skills.
- Manage multiple priorities and adapt to changing study requirements.
- Identify issues, investigate discrepancies, and develop practical solutions.
- Build working relationships with investigators, site personnel, clients, and cross-functional project teams.
- Be able and willing to travel by air or car on short notice, with travel requirements of up to 65%.
- Be proficient in Microsoft Word, Excel, and PowerPoint.
Responsibilities
- Conduct qualification, initiation, interim, and close-out site visits for clinical studies.
- Monitor clinical trials for compliance 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 investigational supplies, including preparation, shipment, dispensing, inventory, reconciliation, and return.
- Monitor laboratory sample storage and shipment activities and maintain appropriate documentation.
- Track and report site enrollment and termination updates, monitoring activities, protocol deviations, serious adverse events, and laboratory abnormalities.
- Review source data, case report forms, data queries, listings, and regulatory documentation for accuracy and completeness; resolve discrepancies with study sites.
- Maintain study files and communicate with investigators, coordinators, study centers, project teams, and other stakeholders.
- Provide guidance and practical solutions to CRA I and CRA II colleagues.
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