Clinical Research Associate (CRA), Oncology Trials
Our client, a rapidly growing pharmaceutical company dedicated to advancing cancer treatments, is seeking a highly skilled and motivated Clinical Research Associate (CRA) to join their clinical development team. This is a fully remote position, offering the flexibility to manage your workload and contribute to life-saving research from your home office. You will be responsible for monitoring clinical trials to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This includes site initiation, routine monitoring visits (remote and potentially on-site as needed), close-out visits, and ensuring accurate and timely data collection. The ideal candidate will possess a strong understanding of oncology research, clinical trial operations, and regulatory compliance.
Key Responsibilities:
Conduct remote and on-site monitoring visits to clinical trial sites to assess protocol adherence, data accuracy, and subject safety. Perform site initiation, interim monitoring, and close-out visits in accordance with study protocols and company SOPs. Verify source data against case report forms (CRFs) and ensure data integrity and query resolution. Ensure compliance with FDA regulations, ICH-GCP guidelines, and study-specific requirements. Train and support site staff on study procedures, protocols, and regulatory requirements. Manage investigational product accountability and ensure proper handling and storage. Build and maintain strong working relationships with principal investigators and site study coordinators. Prepare comprehensive monitoring visit reports and follow up on action items. Identify site-specific issues, implement corrective actions, and escalate as necessary. Contribute to the development and review of study documents, including protocols and CRFs.
Qualifications:
Bachelor's degree in a life science, nursing, or a related field. Minimum of 3-5 years of experience as a Clinical Research Associate (CRA), with a significant focus on oncology trials. In-depth knowledge of clinical trial phases, GCP, ICH guidelines, and FDA regulations. Proven experience in conducting remote monitoring and site management. Excellent understanding of medical terminology and oncology-specific protocols. Strong analytical and problem-solving skills, with meticulous attention to detail. Outstanding communication, interpersonal, and organizational skills. Ability to travel for on-site visits as required (estimated up to 30%). Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems. Self-motivated and able to work independently in a remote environment. This is a fully remote opportunity, allowing you to significantly contribute to advancing cancer therapies while enjoying the benefits of working from home. Join a dedicated team at the forefront of pharmaceutical innovation.
About Our Client: Our client is a leading pharmaceutical company committed to discovering, developing, and delivering innovative medicines to improve patient lives.
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Key Responsibilities:
Conduct remote and on-site monitoring visits to clinical trial sites to assess protocol adherence, data accuracy, and subject safety. Perform site initiation, interim monitoring, and close-out visits in accordance with study protocols and company SOPs. Verify source data against case report forms (CRFs) and ensure data integrity and query resolution. Ensure compliance with FDA regulations, ICH-GCP guidelines, and study-specific requirements. Train and support site staff on study procedures, protocols, and regulatory requirements. Manage investigational product accountability and ensure proper handling and storage. Build and maintain strong working relationships with principal investigators and site study coordinators. Prepare comprehensive monitoring visit reports and follow up on action items. Identify site-specific issues, implement corrective actions, and escalate as necessary. Contribute to the development and review of study documents, including protocols and CRFs.
Qualifications:
Bachelor's degree in a life science, nursing, or a related field. Minimum of 3-5 years of experience as a Clinical Research Associate (CRA), with a significant focus on oncology trials. In-depth knowledge of clinical trial phases, GCP, ICH guidelines, and FDA regulations. Proven experience in conducting remote monitoring and site management. Excellent understanding of medical terminology and oncology-specific protocols. Strong analytical and problem-solving skills, with meticulous attention to detail. Outstanding communication, interpersonal, and organizational skills. Ability to travel for on-site visits as required (estimated up to 30%). Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems. Self-motivated and able to work independently in a remote environment. This is a fully remote opportunity, allowing you to significantly contribute to advancing cancer therapies while enjoying the benefits of working from home. Join a dedicated team at the forefront of pharmaceutical innovation.
About Our Client: Our client is a leading pharmaceutical company committed to discovering, developing, and delivering innovative medicines to improve patient lives.
Apply tot his job
Apply To this Job