IQVIA
IQVIA Biotech is actively seeking a CRA 2 with oncology monitoring experience. If you have at least 1 year of on-site monitoring experience in a clinical environment, we encourage you to apply!
Job Overview:
In this role, you will perform crucial monitoring and site management functions to ensure that study sites follow the study protocol, adhere to regulations, and report study data accurately. Essential Functions: Conduct site monitoring visits, including selection, initiation, monitoring, and close-out in compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Collaborate with sites to enhance participant recruitment in alignment with project goals. Provide protocol training to assigned sites and maintain effective communication to manage project expectations and resolve issues. Assess site practices to ensure protocol compliance and timely escalation of quality issues. Track progress of studies, including regulatory submissions, recruitment efforts, and data management tasks. Ensure proper documentation is maintained for the Trial Master File (TMF) and the Investigator's Site File (ISF) as per GCP and local regulations. Generate reports and correspondence detailing monitoring visit findings and action plans. Work closely with the study team to provide comprehensive project support. Where applicable, assist in site financial management and invoicing processes. Qualifications: Bachelor's degree in a scientific discipline or healthcare preferred. Minimum of 1.5 years of on-site monitoring experience; equivalent education and experience combinations may be accepted. Strong understanding of clinical research regulatory requirements, including GCP and ICH guidelines. Proficient in Microsoft Word, Excel, and PowerPoint, along with familiarity using laptops and mobile devices. Excellent written and verbal communication skills in English. Strong organizational, problem-solving, time management, and financial management skills. Able to establish and maintain effective working relationships with colleagues and clients. IQVIA is dedicated to providing clinical research services and innovative insights to the life sciences and healthcare industries. We invite motivated candidates to join us in our mission to enhance patient outcomes and improve population health worldwide. We are proud to be an equal opportunity employer. All eligible applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or any other status protected by law. The potential base pay range for this role is $69,800.00 - $226,800.00, depending on qualifications, experience, and location.
In this role, you will perform crucial monitoring and site management functions to ensure that study sites follow the study protocol, adhere to regulations, and report study data accurately. Essential Functions: Conduct site monitoring visits, including selection, initiation, monitoring, and close-out in compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Collaborate with sites to enhance participant recruitment in alignment with project goals. Provide protocol training to assigned sites and maintain effective communication to manage project expectations and resolve issues. Assess site practices to ensure protocol compliance and timely escalation of quality issues. Track progress of studies, including regulatory submissions, recruitment efforts, and data management tasks. Ensure proper documentation is maintained for the Trial Master File (TMF) and the Investigator's Site File (ISF) as per GCP and local regulations. Generate reports and correspondence detailing monitoring visit findings and action plans. Work closely with the study team to provide comprehensive project support. Where applicable, assist in site financial management and invoicing processes. Qualifications: Bachelor's degree in a scientific discipline or healthcare preferred. Minimum of 1.5 years of on-site monitoring experience; equivalent education and experience combinations may be accepted. Strong understanding of clinical research regulatory requirements, including GCP and ICH guidelines. Proficient in Microsoft Word, Excel, and PowerPoint, along with familiarity using laptops and mobile devices. Excellent written and verbal communication skills in English. Strong organizational, problem-solving, time management, and financial management skills. Able to establish and maintain effective working relationships with colleagues and clients. IQVIA is dedicated to providing clinical research services and innovative insights to the life sciences and healthcare industries. We invite motivated candidates to join us in our mission to enhance patient outcomes and improve population health worldwide. We are proud to be an equal opportunity employer. All eligible applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or any other status protected by law. The potential base pay range for this role is $69,800.00 - $226,800.00, depending on qualifications, experience, and location.