Clinical Research Coordinator Intermediate

About This Role

This Clinical Research Coordinator Intermediate position provides study coordination for multiple complex clinical research studies. The role involves applying critical thinking and problem-solving skills to enhance clinical research activities and contributing to process development.

Responsibilities

• Assist study team with aspects of clinical research coordination including identifying, screening, consenting, and enrolling subjects
• Collect specimens and monitor study subjects, ensuring integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking)
• Perform data management and results reporting, such as entering information into Case Report Forms (CRFs)
• Assist with collection of external medical records for study reporting purposes
• Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Prepare IRB submissions including initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, and adverse event reports
• Communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject-related problems, recruitment strategies, and specific policies and procedures
• Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies
• Serve as key resource to research participants and collaborators
• Provide support for audits and monitor visits
• Mentor and train other CRC staff through formal and informal presentations

Requirements

• Bachelor's degree in Health Science or equivalent
• Certification through ACRP as a CCRC or SOCRA as a CCRP (or equivalent), must be eligible to register/take exam at hire and complete within six months
• Minimum 3 years of directly related experience in clinical research and clinical trials

Qualifications

• Bachelor's degree in Health Science or an equivalent combination of related education and experience
• Minimum 3 years of directly related experience in clinical research and clinical trials

Nice to Have

• 6+ years of direct related experience

Certifications