Clinical Research Associate III
Our client is seeking a highly skilled and experienced Clinical Research Associate III to contribute to groundbreaking pharmaceutical research in Milwaukee, Wisconsin . This hybrid role offers the unique opportunity to blend critical on-site responsibilities with remote flexibility. As a CRA III, you will play a pivotal role in ensuring the quality and integrity of clinical trials by monitoring study sites, verifying data, and ensuring compliance with protocols and regulatory requirements. Your meticulous attention to detail and deep understanding of clinical research processes will be essential for success.
Key Responsibilities: Conduct pre-study, interim, and close-out site visits to assess protocol and regulatory compliance. Monitor study conduct, ensuring adherence to Good Clinical Practice (GCP) guidelines, study protocols, and Standard Operating Procedures (SOPs). Verify accuracy and completeness of clinical data through source document review. Manage site relationships, providing training and support to investigators and site staff. Ensure timely submission of required regulatory documents and study materials. Identify, document, and resolve site-level issues and deviations. Prepare site visit reports and track action items for resolution. Participate in investigator meetings and training sessions. Contribute to the development and review of study-related documents, such as protocols and case report forms. Ensure all trial-related monitoring activities are documented accurately and comprehensively.
Qualifications: Bachelor's degree in a life science, nursing, or related scientific discipline. Master's degree preferred. Minimum of 5 years of experience as a Clinical Research Associate (CRA) or equivalent role. In-depth knowledge of GCP, FDA regulations, and ICH guidelines. Proven experience in conducting site monitoring visits for various therapeutic areas. Strong understanding of clinical trial processes and documentation. Excellent written and verbal communication skills, with the ability to communicate effectively with healthcare professionals and internal teams. Exceptional organizational skills and attention to detail. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Ability to travel as required for site visits (estimated 40-60%). Certified Clinical Research Associate (CCRA) certification is a strong plus. This position requires a blend of remote work and on-site presence in the Milwaukee, Wisconsin area to effectively manage local study sites. You will be integral to the success of critical pharmaceutical development programs.
Key Responsibilities: Conduct pre-study, interim, and close-out site visits to assess protocol and regulatory compliance. Monitor study conduct, ensuring adherence to Good Clinical Practice (GCP) guidelines, study protocols, and Standard Operating Procedures (SOPs). Verify accuracy and completeness of clinical data through source document review. Manage site relationships, providing training and support to investigators and site staff. Ensure timely submission of required regulatory documents and study materials. Identify, document, and resolve site-level issues and deviations. Prepare site visit reports and track action items for resolution. Participate in investigator meetings and training sessions. Contribute to the development and review of study-related documents, such as protocols and case report forms. Ensure all trial-related monitoring activities are documented accurately and comprehensively.
Qualifications: Bachelor's degree in a life science, nursing, or related scientific discipline. Master's degree preferred. Minimum of 5 years of experience as a Clinical Research Associate (CRA) or equivalent role. In-depth knowledge of GCP, FDA regulations, and ICH guidelines. Proven experience in conducting site monitoring visits for various therapeutic areas. Strong understanding of clinical trial processes and documentation. Excellent written and verbal communication skills, with the ability to communicate effectively with healthcare professionals and internal teams. Exceptional organizational skills and attention to detail. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Ability to travel as required for site visits (estimated 40-60%). Certified Clinical Research Associate (CCRA) certification is a strong plus. This position requires a blend of remote work and on-site presence in the Milwaukee, Wisconsin area to effectively manage local study sites. You will be integral to the success of critical pharmaceutical development programs.