CLINICAL RESEARCH COORDINATOR I

Duties And Responsibilities

• Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Coverage studies from startup through close-out.
• Incorporate clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.
• Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
• Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Ensure adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Establish and maintain research project’s regulatory files.
• Ongoing communication with the local IRB, federal organizations, affiliate institutions, and pharmaceutical study sponsors.
• Data Management Responsibilities:
• Collects, records, and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines.
• Clarifies Data Queries.
• Specimen Handling and Shipping Responsibilities:
• Coordinates with the Clinical Research RN to organize procurement of research samples and then prepares, packages, and ships research samples.
• Manages research sample supplies.
• Participates in Cooperative Group Audits, FDA, Sponsor GCP quality audits, Loyola internal audits, and department audits.

Qualifications

• Bachelor’s Degree OR equivalent training acquired via work experience or education.
• Experience with oncology population preferred.
• Project management skills.
• Excellent written and verbal communication skills.
• Experience working in clinical trials highly desirable.
• CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is desired.
• Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon, Clinical Trials Management System, Electronic data entry web based data bases.

Supervisory Responsibilities

No

Physical Demands

None

Working Conditions

None