Specialized research professional working with and under the direction of the Principal Investigator (PI) and the Lindner Center for Research and Education. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC ensures quality, human subject safety and data integrity of the clinical trial. By performing these duties, the CRC works with the PI, department, sponsor, Lindner Center and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
Study Conduct/Clinical Research Practice
• Maintain awareness of status of all active studies.
• Arrange for facilities and supplies.
• Ensure participant and study compliance, i.e. 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 visit in conjunction with other(s), such as PI, and/or other clinical services.
Regulatory Compliance and Documentation
• 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 to ensure compliance to those regulations.
Recruitment, Enrollment, and Retention
• Determine best method(s)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 study.
• Track progress and report to appropriate source and PI
• Conduct pre-consent screening to determine eligibility. Review consent form with participant and perform the informed consent process.
Data Management
• 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
Communication
• Compose, document, organize, and maintain all correspondence. Oversee and follow through on questions and issues that arise during study conduct.
• Serve as liaison to internal departments, clinical teams, regulatory agencies and participant(s).
• Develop a rapport with participating physicians, staff and study participants.
KNOWLEDGE AND SKILLS:
Please describe any specialized knowledge or skills, which are REQUIRED to perform the position duties. Do not personalize the job description, credentials, or knowledge and skills based on the current associate. List any special education required for this position.
EDUCATION: Bachelor’s degree required; Masters preferred
YEARS OF EXPERIENCE: 2-4 years clinical research experience with conducting clinical trials/studies
REQUIRED SKILLS AND KNOWLEDGE: Photocopier, fax equipment, software and database skills, all medical equipment appropriate to research and strong organizational and communication skills.
LICENSES & CERTIFICATIONS :
Preferred clinical research certifications, such as CCRA or other applicable research certifications. BLS required.
