Clinical Research Coordinator II

About This Role

Managing multiple clinical trial protocols and coordinating their execution and follow-up is the core of this role. The Clinical Research Coordinator II ensures accurate documentation and promotes Principal Investigator oversight by advising on deviations, patient status, and trial integrity issues. This position suits detail-oriented individuals with strong teamwork skills who can perform multiple tasks efficiently under pressure.

Responsibilities

• Manage multiple clinical trial protocols and coordinate execution and follow-up
• Perform accurate documentation and promote Principal Investigator oversight
• Advise on deviations, patient status, and trial integrity issues
• Review informed consent documents with study candidates and ensure patient advocacy
• Coordinate support staff, laboratory technicians, and assistants for efficient results
• Serve as a liaison between Principal Investigators, the Institutional Review Board, and the Office of Sponsored Programs
• Prepare and review documentation for clinical research study start-up, execution, modification, renewal, and termination
• Maintain current knowledge of regulatory requirements and implement changes as needed
• Collaborate with study sponsors and assist site monitors during visits
• Communicate effectively with healthcare team members, patients, investigators, sponsors, and administration
• Manage records, study medication, and test articles confidentially and securely

Requirements

• Bachelor's degree [Required]
• Minimum of two to five years of experience in clinical research [Required]
• Specialized knowledge of the unique needs of patients undergoing treatment in research trials
• Critical thinker with an analytical approach to problem-solving
• Working knowledge of Microsoft Office applications, such as Word, Excel, Access, Outlook
• Demonstrated proficiency in clinical study coordination across a spectrum of trial acuities
• Knowledge of Federal regulations: FDA, CDC, DHHS
• Bilingual (English/Spanish) [Preferred]

Nice to have:

• Cardiology experience [Preferred]
• Other certification as applicable to degree or program (i.e., medical assistant, medical technician, phlebotomy)

Benefits

• Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance
• Paid Time Off from Day One
• 403-B Retirement Plan
• 4 Weeks 100% Paid Parental Leave
• Career Development
• Whole Person Well-being Resources
• Mental Health Resources and Support