Clinical Research Coordinator

Roles and Responsibilities

• Maintains GCP/ICH guidelines and FDA regulations.
• Coordinates study start-up activities, including IRB submission, site initiation visits, and pre-study visits.
• Serves as the primary point of contact for sponsors.
• Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Tracks enrollment status of patients and documents dropout information such as dropout causes and patient contact efforts.
• Affords potential patients' eligibility through methods like screening interviews, reviewing medical records, and discussions with physicians and assistant physician providers.
• Responsible for education and appropriate documentation of patient informed consent.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Participates in preparation and management of research budgets and monetary disbursements.
• Conducts monitoring visits and resolves issues as needed in a timely manner.
• Mentors and trains junior research staff and new team members on study protocol, procedures and regulatory compliance.

Skill Requirements and Qualifications

• Biology or Health Science degree, preferred.
• Fluency in Spanish preferred.
• At least three years of experience in clinical research coordination, preferably cardiology.
• Clinical experience preferred.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred.
• Strong organizational and analytical skills required.
• In depth knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements.
• Proficiency and clinical trial management systems and electronic data capture platforms.
• Flexibility with working hours to accommodate study needs.
• Detailed oriented, excellent written and verbal communication skills.
• Excellent time management skills, team player with the ability to work independently.
• EMR experience, (EPIC a plus) and Microsoft Excel, Word and Outlook.