Clinical Research Coordinator II Job at INTERCOASTAL MEDICAL GROUP in Sarasota

Benefits

Qualifications

• •Bachelor’s degree or higher in a health-related field
• •At least 3 years of experience coordinating clinical research studies in a healthcare or academic setting
• •Knowledge of clinical research regulations, including FDA, IRB, and GCP guidelines
• •Strong organizational skills with the ability to manage multiple studies simultaneously
• •Proficiency in electronic data capture systems and Microsoft Office Suite
• •The Clinical Research Coordinator II utilizes strong organizational and communication skills daily to manage complex clinical trial logistics and ensure protocol adherence
• •Attention to detail is critical when maintaining accurate study documentation and handling regulatory submissions
• •Proficiency with electronic data capture systems and Microsoft Office tools supports efficient data management and reporting
• •Interpersonal skills enable effective collaboration with investigators, participants, and sponsors, fostering a cooperative research environment
• •Additionally, problem-solving abilities are essential to address challenges that arise during study conduct and to implement process improvements
• •Intercoastal is a drug free workplace and EEO compliant
• •8 more items(s)

Responsibilities

• •The Clinical Research Coordinator II plays a pivotal role in the successful execution and management of clinical research studies within healthcare settings
• •This position is responsible for coordinating all aspects of clinical trials, ensuring compliance with regulatory requirements, and maintaining the integrity and accuracy of study data
• •The coordinator will serve as a liaison between investigators, study participants, sponsors, and regulatory bodies to facilitate smooth study operations
• •They will oversee participant recruitment, informed consent processes, and data collection while monitoring adherence to study protocols
• •Ultimately, this role contributes to advancing medical knowledge and improving patient care through rigorous clinical research
• •Coordinate and manage day-to-day activities of clinical research studies, including participant recruitment, screening, enrollment, and follow-up
• •Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements such as FDA and IRB guidelines
• •Maintain accurate and detailed study documentation, including case report forms, regulatory binders, and electronic data capture systems
• •Collaborate with principal investigators, research staff, and external sponsors to facilitate study progress and resolve any issues
• •Monitor participant safety and report adverse events promptly according to protocol and regulatory standards
• •Schedule and conduct study visits, collect biological samples, and administer study-related procedures as required
• •Assist in the preparation and submission of regulatory documents and study reports
• •Train and mentor junior research staff and support continuous quality improvement initiatives within the research team
• •10 more items(s)