2 Senior Clinical Research Associate Remote Monitoring jobs in whatjobs
Senior Clinical Research Associate, Remote Monitoring
Posted 7 days ago
Job Viewed
Job Description
Our client, a global leader in pharmaceutical research and development, is actively seeking a highly experienced Senior Clinical Research Associate (CRA) to join their dedicated, fully remote clinical operations team. This critical role involves overseeing and monitoring clinical trials remotely, ensuring data integrity, patient safety, and adherence to regulatory standards (GCP, ICH). You will be responsible for managing site relationships, conducting remote source data verification, reviewing trial documentation, and troubleshooting issues that arise during the trial lifecycle. The ideal candidate will possess a strong background in clinical research, a meticulous attention to detail, and exceptional communication and organizational skills. As this is a 100% remote position, you will leverage advanced technologies and virtual collaboration tools to maintain effective oversight of clinical trial sites and progress. Your expertise will be vital in ensuring the successful execution of critical drug development programs.
Responsibilities:
Responsibilities:
- Conduct remote monitoring of clinical trial sites to ensure adherence to protocols, GCP, and regulatory requirements.
- Perform remote source data verification (SDV) and review case report forms (CRFs) for accuracy and completeness.
- Manage and build strong relationships with principal investigators and site staff.
- Oversee patient safety and ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
- Review essential trial documents, including investigational plans, consent forms, and regulatory binders.
- Identify, document, and track site issues and implement corrective and preventative actions (CAPAs).
- Provide training and guidance to clinical trial site personnel on study protocols and procedures.
- Ensure timely site initiation, monitoring visits (remote or on-site as needed), and site closure.
- Prepare monitoring reports and communicate findings to the clinical study team and management.
- Contribute to the development of study-related documents, including monitoring plans and risk assessment tools.
- Maintain up-to-date knowledge of regulatory guidelines and industry best practices.
- Effectively utilize clinical trial management systems (CTMS) and electronic data capture (EDC) systems for remote monitoring activities.
- Bachelor's degree in a life science, nursing, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
- Extensive knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in remote clinical trial monitoring and data verification.
- Strong understanding of clinical trial processes from study start-up to close-out.
- Excellent organizational, time management, and prioritization skills.
- Exceptional written and verbal communication skills, with the ability to clearly articulate findings and recommendations.
- Proficiency with clinical trial software, including CTMS and EDC systems.
- Ability to work independently and as part of a remote, cross-functional team.
- Detail-oriented with a strong commitment to quality and patient safety.
- Willingness to travel on-site occasionally as required by specific study needs (though the role is primarily remote).
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Senior Clinical Research Associate - Remote Monitoring
Posted 14 days ago
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Job Description
Our client, a prominent pharmaceutical company, is seeking a highly diligent and experienced Senior Clinical Research Associate (CRA) to oversee clinical trial activities. This is a fully remote position, allowing you to manage your responsibilities from anywhere while focusing on trials impacting patient populations near Ongata Rongai, Kajiado, KE . You will be responsible for ensuring the quality, integrity, and compliance of clinical trials by monitoring study sites, verifying data accuracy, and ensuring adherence to protocols and regulatory guidelines (e.g., GCP, FDA). The ideal candidate will possess a strong background in clinical trial management, excellent understanding of regulatory requirements, and a keen eye for detail. You will conduct remote site visits, review source documents, resolve data discrepancies, and manage communication between study sites, internal teams, and regulatory authorities. This role requires exceptional organizational skills, a proactive approach to problem-solving, and the ability to work independently and effectively in a remote setting. Experience with various therapeutic areas and electronic data capture (EDC) systems is essential. You will play a crucial role in advancing new therapies through rigorous clinical evaluation, ensuring patient safety and data integrity throughout the process. This is an outstanding opportunity to contribute to significant medical advancements from the convenience of a remote work environment.
Qualifications:
Qualifications:
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 5 years of experience as a Clinical Research Associate.
- In-depth knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Proven experience in remote site monitoring and data verification.
- Proficiency with Electronic Data Capture (EDC) systems and clinical trial management software.
- Excellent attention to detail and organizational skills.
- Strong problem-solving and decision-making abilities.
- Effective communication and interpersonal skills for site staff and team collaboration.
- Ability to work independently and manage multiple study sites in a remote capacity.
- Experience in specific therapeutic areas is a plus.
This advertiser has chosen not to accept applicants from your region.
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