Clinical Research Coordinator II - Part Time - Days

Christ Hospital • OH, OH

343d

About The Position

The Specialized Research Professional will work closely with and under the direction of the Principal Investigator (PI) and the Lindner Center for Research and Education. The PI is primarily responsible for the overall design, conduct, and management of the clinical trial, while the Clinical Research Coordinator (CRC) supports, facilitates, and coordinates the daily clinical trial activities. The CRC plays a critical role in ensuring quality, human subject safety, and data integrity of the clinical trial. This position involves collaboration with the PI, department, sponsor, Lindner Center, and institution to provide guidance on compliance, financial, personnel, and other related aspects of the clinical study.

Requirements

• Bachelor's degree required; Master's preferred.
• 2-4 years clinical research experience with conducting clinical trials/studies.
• Proficiency with photocopier, fax equipment, software and database skills, and all medical equipment appropriate to research.
• Strong organizational and communication skills.

Nice To Haves

• Preferred clinical research certifications, such as CCRA or other applicable research certifications.

Responsibilities

• Maintain awareness of status of all active studies.
• Arrange for facilities and supplies.
• Ensure participant and study compliance, including collection of specimens or data.
• Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies.
• Register, schedule, and conduct clinical study visits in conjunction with the PI and/or other clinical services.
• Ensure accurate and timely preparation, submission, and maintenance of all regulatory submissions (proposed new studies, annual review, amendments, adverse events).
• Oversee the review, correspondence, and approval of human research protocols with regulatory authorities, including study close out.
• Apply legal, regulatory, and policy parameters to promote ethical practices in research involving human participants and ensure compliance with those regulations.
• Determine best methods to identify potential participants for research protocols (advertisements, chart review, monitoring of clinic schedules, etc.).
• Create and maintain a detailed tracking system for participants enrolled in the study.
• Track progress and report to appropriate sources and the PI.
• Conduct pre-consent screening to determine eligibility and review consent forms with participants, performing the informed consent process.
• Oversee creation of case report forms (CRFs) in consultation with other team members, using existing study data information to promote efficient data collection and data entry.
• Complete CRFs and source documentation in compliance with all applicable guidelines for human research.
• Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
• Review documentation from sources to ensure accuracy.
• Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation.
• Assist in data analysis and maintain record keeping and data storage.
• Compose, document, organize, and maintain all correspondence.
• Serve as liaison to internal departments, clinical teams, regulatory agencies, and participants.
• Develop a rapport with participating physicians, staff, and study participants.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Hospitals
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees