Clinical Research Coordinator II

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. He/she participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. 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. Report all serious adverse events promptly to investigators, sponsors and the IRB. Protect the rights, safety and well-being of human subjects involved in the clinical trials.

Responsibilities of the CRC II include all the duties and responsibilities if CRC I, as well as the following:
Coordination 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. 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.
* 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.
Regulatory responsibilities:
* Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations.
-Stepanenko, Nataliia

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.

Founded in 1870, Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With 15 schools, colleges, and institutes-including Business, Law, Medicine, Nursing, and Health Sciences-Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation's top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world.

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