ICON Strategic Solutions
Senior Recruiting Specialist - ICON Strategic Solutions
Early development Oncology • Must have 2 years of onsite monitoring experience • Oncology experience • Must have phase I/II experience • local/regional travel Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance. Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs. Travel at least 60% of the time (international and domestic: fly and drive). Expert knowledge of ICON's SOPs/WPs, ICH, GCP and applicable regulations. Familiarity with ICON systems. Maintain timelines and ensure accuracy and completeness of data entered into ICON systems. Recruitment of investigators. Coordinate activities required to set up and monitor a study, including identifying investigators and regulatory submissions support. Prepare patient information sheets and consent forms; ensure timely submission of protocol/consent documents for ethics/IRB approval. Conduct pre-study/placement and initiation visits; perform monitoring visits in line with ICON and sponsor SOPs. Maintain study files and documentation; motivate investigators to achieve recruitment targets; complete accurate study status reports. Ensure correct storage and accounting of drugs in accordance with SOPs. Keep the Project Manager regularly informed. Process case report forms to required quality standards and timelines; respond to sponsor queries promptly. Ensure satisfactory closeout of investigator sites. Assist in preparation and review of study documentation (e.g., draft protocols, draft CRFs, monitoring guidelines, final report elements). Participate in feasibility studies for new proposals; ensure correct archiving of files on completion of a study. Maintain patient and sponsor confidentiality. Assume additional responsibilities as directed by the Project Manager. Manage investigational products (IPs) at the site: storage conditions, supply to eligible patients, receipt/use/return control and documentation, disposition in accordance with regulatory requirements and sponsor guidance. Lead role on a study as appropriate; participate in data listing reviews and training/mentoring new staff up to CRA level. Support marketing of the company when appropriate. Other duties as assigned. We are seeking a Clinical Research Associate Early Development in the Northeast region to join our team. As a Clinical Research Associate, you will contribute to designing and analyzing clinical trials, interpreting data, and advancing innovative treatments. What you will be doing Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensure protocol compliance, data integrity, and patient safety throughout the trial process. Collaborate with investigators and site staff to facilitate smooth study conduct. Perform data review and resolution of queries to maintain high-quality clinical data. Contribute to study documentation including protocols and clinical study reports. Your profile Bachelor's degree in a scientific or healthcare-related field. Minimum of 3 years of experience as a Clinical Research Associate and 2 years in Early Development Oncology/Hematology. Must be located in NY, NJ, PA, NH, CT, RI or MA. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic) and possess a valid driver’s license. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Early development Oncology • Must have 2 years of onsite monitoring experience • Oncology experience • Must have phase I/II experience • local/regional travel Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance. Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs. Travel at least 60% of the time (international and domestic: fly and drive). Expert knowledge of ICON's SOPs/WPs, ICH, GCP and applicable regulations. Familiarity with ICON systems. Maintain timelines and ensure accuracy and completeness of data entered into ICON systems. Recruitment of investigators. Coordinate activities required to set up and monitor a study, including identifying investigators and regulatory submissions support. Prepare patient information sheets and consent forms; ensure timely submission of protocol/consent documents for ethics/IRB approval. Conduct pre-study/placement and initiation visits; perform monitoring visits in line with ICON and sponsor SOPs. Maintain study files and documentation; motivate investigators to achieve recruitment targets; complete accurate study status reports. Ensure correct storage and accounting of drugs in accordance with SOPs. Keep the Project Manager regularly informed. Process case report forms to required quality standards and timelines; respond to sponsor queries promptly. Ensure satisfactory closeout of investigator sites. Assist in preparation and review of study documentation (e.g., draft protocols, draft CRFs, monitoring guidelines, final report elements). Participate in feasibility studies for new proposals; ensure correct archiving of files on completion of a study. Maintain patient and sponsor confidentiality. Assume additional responsibilities as directed by the Project Manager. Manage investigational products (IPs) at the site: storage conditions, supply to eligible patients, receipt/use/return control and documentation, disposition in accordance with regulatory requirements and sponsor guidance. Lead role on a study as appropriate; participate in data listing reviews and training/mentoring new staff up to CRA level. Support marketing of the company when appropriate. Other duties as assigned. We are seeking a Clinical Research Associate Early Development in the Northeast region to join our team. As a Clinical Research Associate, you will contribute to designing and analyzing clinical trials, interpreting data, and advancing innovative treatments. What you will be doing Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensure protocol compliance, data integrity, and patient safety throughout the trial process. Collaborate with investigators and site staff to facilitate smooth study conduct. Perform data review and resolution of queries to maintain high-quality clinical data. Contribute to study documentation including protocols and clinical study reports. Your profile Bachelor's degree in a scientific or healthcare-related field. Minimum of 3 years of experience as a Clinical Research Associate and 2 years in Early Development Oncology/Hematology. Must be located in NY, NJ, PA, NH, CT, RI or MA. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic) and possess a valid driver’s license. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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