Clinical Research Associate

Senior Recruiting Specialist – ICON Strategic Solutions

We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

• 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 resolve queries to maintain high‑quality clinical data.
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports.
• Recruit investigators, identify investigators, and participate in feasibility studies for new proposals.
• Assist in the preparation of regulatory submissions, design of patient information sheets and consent forms, and timely submission of IRB approval documents.
• Maintain all files and documentation pertaining to studies; motivate investigators to achieve recruitment targets; complete accurate study status reports.
• Ensure proper storage of investigational products, including receipt, use, return, and disposition of unused items in accordance with regulations.
• Maintain drug storage conditions and account for all drugs in accordance with SOPs.
• Process case record forms to required quality standards and timelines; deal with sponsor‑generated queries promptly.
• Ensure satisfactory closeout of investigator sites; ensure correct archiving of files upon study completion.
• Keep the Project Manager regularly informed; assume additional responsibilities as directed by the Project Manager.
• Participate in data listing reviews, training and mentoring of new staff up to Clinical Research Associate level, and in marketing initiatives as appropriate.
• Perform additional duties as assigned.

• Bachelor's degree in a scientific or healthcare‑related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• 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.
• Travel availability up to 60% of the time (international and domestic) and a valid driver’s license.
• Expert knowledge of ICON SOPs/WPs, ICH, GCP, and appropriate regulations.
• Familiarity with ICON systems.

Recognize, exemplify, and adhere to ICON’s values which center on People, Clients, and Performance. As a member of staff, you will embrace and contribute to our culture of process improvement, streamline processes, add value, and meet client needs.