Research Coordinator 2 (E S UAW Research)

About the role

The Division of Cardiology in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator 2. This position reports to the Clinical Research Manager and promotes the research objectives of the Clinical Trials Unit (CTU).

Responsibilities

• Implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution and federal regulations.
• Develop, document, and maintain procedures for patient registration and activities, and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
• Care for patient recruitment and management, study data collection and management, and study administration.
• Coordinate and conduct study visits and activities, record and collect study data, complete data entry, maintain study source records, and resolve queries based on source documentation.
• Work with Regulatory Coordinator to develop and implement study tools and source documents, maintain regulatory documents, and review and complete regulatory submissions to Institutional Review Boards and other regulatory and reviewing boards.
• Facilitate and track study visits, tests, and procedures in accordance with the protocol, ensuring billing compliance, and accurate and complete data collection, including informed consent forms and source documentation.
• Obtain, abstract, and code clinical information from multiple sources (medical records, research records, etc) for research participants in order to enter data into study specific data capture systems, and to document, assess, and report adverse events and safety data to study investigators, sponsors, IRB’s and other regulatory authorities when applicable.
• Work with monitors and sponsors to facilitate study site visits, and, with limited guidance, develop and implement corrective action plans to ensure protocol adherence, and data integrity, and to resolve queries in a timely manner.

Qualifications

• Bachelor’s degree in biological sciences or a related field and two years of relevant experience.
• Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
• Prior experience with industry-sponsored and/or interventional clinical trials.
• Effective written and oral communication skills.
• A high attention to detail, and demonstrated excellent organizational skills.
• Demonstrated problem-solving skills and comfort being flexible and adaptable in a fast-paced environment.
• A self-starter with ability to work independently, with limited guidance, or in novelty.