Clinical Research Coordinator II

Position Details

Job Title:

CLINICAL RESEARCH COORDINATOR II

Position Number: 8150021

Job Category:
University Staff

Job Type: Full-Time

FLSA Status:
Non-Exempt

Campus:
Maywood-Health Sciences Campus

Department Name: HEMATOLOGY ONCOLOGY

The Clinical Research Coordinator II is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Loyola University Medical Center and satellites. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research in coordination with Clinical Research Nurse.

Responsibilities include assisting in the preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advise the IRB of amendment changes to the protocol and complete annual protocol renewals. Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations.

The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment. Maintain drug accountability, adequate study supplies and equipment. The coordinator will oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject's medical record.

• 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. Coordinate studies from startup through close-out.
• In collaboration with the PI & RN, incorporates 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.

Bachelors Degree OR equivalent training acquired via work experience or education and 2-5 years of previous job-related experience

• Ability to follow oral and written instructions and established procedures
• May require use of centrifuge, make slides for labs, ECG's to be performed and transmitted.
• Medication administration

SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.

Should have basic knowledge in Excel, WORD, EPIC (EMR for the hospital), and Internet based data submission.

Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education.