2 Clinical Research Associate Ii jobs in whatjobs
Clinical Research Associate II
Posted 14 days ago
Job Viewed
Job Description
Our client is seeking a dedicated and detail-oriented Clinical Research Associate II (CRA II) to join their growing pharmaceutical research team. This hybrid role offers a blend of remote work flexibility and essential on-site engagement. As a CRA II, you will play a vital role in ensuring the quality and integrity of clinical trials by monitoring study sites, verifying data accuracy, and ensuring compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines. You will be responsible for site selection, initiation, monitoring, and close-out visits, as well as resolving data discrepancies and addressing protocol deviations. The ideal candidate will possess strong organizational skills, excellent communication abilities, and a thorough understanding of clinical trial processes. This position requires the ability to travel to study sites as needed while also effectively managing tasks remotely. You will contribute to the development of life-saving medicines by maintaining high standards throughout the clinical research process.
Responsibilities:
Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits to clinical trial sites.
- Verify that study conduct is in compliance with the approved protocol, GCP, and applicable regulations.
- Ensure accurate, complete, and timely collection and review of clinical data.
- Train and support site staff on study procedures and requirements.
- Resolve data queries and address protocol deviations.
- Manage site-level regulatory documentation.
- Build and maintain strong working relationships with investigators and site staff.
- Prepare visit reports and communicate findings to the study team.
- Ensure adherence to project timelines and budgets.
- Contribute to the development of study-related documents.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA).
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience with various therapeutic areas is a plus.
- Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent written and verbal communication skills.
- Strong organizational, time management, and problem-solving abilities.
- Ability to travel up to 50% of the time to study sites.
- Detail-oriented with a commitment to data quality and integrity.
- Experience in pharmaceutical or biotechnology settings is preferred.
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Clinical Research Associate II
Posted 3 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical research organization, is seeking a qualified and experienced Clinical Research Associate II (CRA II) to join their expanding, fully remote global team. This critical role involves the monitoring and management of clinical trial sites to ensure adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The CRA II will be responsible for initiating, monitoring, and closing out clinical sites, performing essential site visits (initiation, interim, and close-out), and ensuring accurate and timely data collection. You will act as the primary liaison between the sponsor and the investigative sites, providing essential support and guidance to site staff. Key responsibilities include verifying data integrity, reviewing source documents, ensuring investigational product accountability, and addressing any issues or discrepancies that arise. A strong understanding of ICH-GCP, FDA regulations, and other relevant regulatory standards is paramount. This position requires exceptional organizational skills, meticulous attention to detail, and the ability to manage multiple priorities in a complex environment. As a fully remote CRA II, you will leverage advanced communication and technology tools to maintain effective oversight and collaboration with sites and internal project teams across different geographical locations. You will be instrumental in the successful execution of clinical trials, contributing to the development of life-saving therapies. This role offers significant opportunities for professional growth, professional development, and the chance to work with a dedicated and supportive team committed to advancing medical science. If you are a seasoned CRA looking for a challenging and rewarding remote opportunity, we invite you to apply.
Responsibilities:
Responsibilities:
- Conduct site initiation, interim monitoring, and close-out visits according to protocol and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
- Ensure compliance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and all applicable local regulations.
- Serve as the main point of contact for assigned investigative sites, fostering strong relationships with investigators and site staff.
- Train site personnel on study protocols, investigational product, and study procedures.
- Monitor study progress and troubleshoot any issues or deviations that arise at the site level.
- Ensure timely submission of essential documents and reports.
- Manage investigational product accountability and distribution at the sites.
- Prepare site visit reports and follow up on action items.
- Contribute to the development of study-related documents as needed.
- Bachelor's degree in a life science, nursing, or a related field.
- Minimum of 2-3 years of experience as a Clinical Research Associate.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Proven experience in monitoring clinical trial sites.
- Excellent communication, interpersonal, and organizational skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and manage a remote workload effectively.
- Willingness to travel for site visits as required (though the role is predominantly remote).
- Fluency in English, both written and spoken.
This advertiser has chosen not to accept applicants from your region.
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