Clinical Research Coordinator II - MOB Lindner Research HV - Full Time - Days

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Aid in data analysis and maintain record keeping and data storage.
• 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.

Qualifications

• Specialized knowledge or skills, which are REQUIRED to perform the position duties.
• List any special education required for this position.
• 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.
• Preferred clinical research certifications, such as CCRA or other applicable research certifications.