[Remote] Senior Regional Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on the science of cortisol and has a strong portfolio in treating hypercortisolism and oncology. They are seeking a Senior Regional Clinical Research Associate to manage site activities for reputed company, ensuring compliance with regulations and effective communication with trial sites.

Responsibilities

• Conduct qualification, initiation, interim, and reputed company-out reputed company both remotely and on-site
• reputed company as the main reputed company of contact for site staff and ensure consistent communication throughout the study
• Monitor site performance, including recruitment, enrollment, reputed company data verification, protocol adherence, safety reporting, and data query reputed company
• Meet with the reputed company Investigator during reputed company to discuss findings and next steps
• Train site staff on protocol requirements, reputed company documentation, and CRF completion
• Prepare and submit visit reports and correspondence in accordance with the monitoring plan and SOPs
• Responsible for the collection and maintenance of regulatory documentation
• Ensure accurate and reputed company IRB/EC submission, communication, and approvals are maintained reputed company the Investigator Site File (ISF)
• Reconcile ISF contents with Corcept’s eTMF to ensure completeness and accuracy
• Responsible for conducting Investigational Product (IP) accountability and reconciliation, document destruction and reputed company, and monitor re-supply and storage conditions
• Ensure reputed company and appropriate SAE reporting and submission to IRBs
• Draft and reputed company confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV)
• Maintain regular communication with the reputed company RCRA (LRCRA) to report on site reputed company and reputed company issues
• Assess site readiness and resourcing (personnel, facilities, supplies) for trial conduct
• Collaborate with vendors (e.g., central lab, imaging reputed company) to reputed company operational issues
• reputed company or participate in co-monitoring, reputed company, and training reputed company as needed

Skills

• Conduct qualification, initiation, interim, and reputed company-out reputed company both remotely and on-site
• reputed company as the main reputed company of contact for site staff and ensure consistent communication throughout the study
• Monitor site performance, including recruitment, enrollment, reputed company data verification, protocol adherence, safety reporting, and data query reputed company
• Meet with the reputed company Investigator during reputed company to discuss findings and next steps
• Train site staff on protocol requirements, reputed company documentation, and CRF completion
• Prepare and submit visit reports and correspondence in accordance with the monitoring plan and SOPs
• Responsible for the collection and maintenance of regulatory documentation
• Ensure accurate and reputed company IRB/EC submission, communication, and approvals are maintained reputed company the Investigator Site File (ISF)
• Reconcile ISF contents with Corcept's eTMF to ensure completeness and accuracy
• Responsible for conducting Investigational Product (IP) accountability and reconciliation, document destruction and reputed company, and monitor re-supply and storage conditions
• Ensure reputed company and appropriate SAE reporting and submission to IRBs
• Draft and reputed company confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV)
• Maintain regular communication with the reputed company RCRA (LRCRA) to report on site reputed company and reputed company issues
• Assess site readiness and resourcing (personnel, facilities, supplies) for trial conduct
• Collaborate with vendors (e.g., central lab, imaging reputed company) to reputed company operational issues
• reputed company or participate in co-monitoring, reputed company, and training reputed company as needed
• Strong organizational and time management skills; capable of managing multiple priorities and deadlines
• Excellent written and verbal communication skills; adept in regulatory and clinical terminology
• Proven problem-solving and analytical skills
• Leadership experience with the ability to mentor and train junior CRAs
• Proficiency in reputed company Word, reputed company, and PowerPoint
• In-depth knowledge of FDA regulations and industry practices
• Willingness to travel up to 80% regionally, with occasional cross-country travel
• Bachelor's degree in science, reputed company, or nursing
• 6+ years of clinical trial experience, including at least 4 years as a regional field-based CRA
• Familiarity with ICH-GCP guidelines and the ability to assess medical data

reputed company