Our client is seeking a highly motivated and experienced Clinical Research Coordinator II to independently manage key aspects of large-scale clinical studies or oversee all components of smaller research projects.
This role offers a dynamic hybrid work environment and the opportunity to contribute to groundbreaking medical research.
Key Responsibilities
Lead subject recruitment and enrollment efforts; develop strategies to retain participants in long-term trials
Manage data systems for collection, reporting, and monitoring; extract and interpret complex datasets
Develop project timelines, milestones, and documentation; prepare meeting minutes and progress reports
Ensure regulatory compliance and lead corrective action initiatives; oversee IRB submissions and responses
Collaborate with investigators and sponsors; monitor adverse events and resolve study-related queries
Recommend and implement process improvements; define and document best practices
Assist in budget development and sponsor invoicing; track patient milestones and study deliverables
Maintain ongoing regulatory documentation and compliance inspections
Support FDA IND submissions and IRB renewals as needed
Perform other duties as assigned
Required Qualifications
Bachelor’s degree in a related field
Minimum of 2 years of clinical research experience or equivalent combination of education and experience
Strong interpersonal and communication skills
Proficiency in Microsoft Office and database applications
Familiarity with HIPAA, FDA regulations, IRB processes, and Good Clinical Practices
Solid understanding of medical terminology
Certification from the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)