Clinical Research Coordinator - Heart Vascular Research - Days

Full-time (80 hours biweekly)

Weekdays, daytime hours

Hybrid Work Options

 

General Summary

Designs, coordinates and conducts designated research activities and provides related education, resources and consultation for staff members. Manages a system for planning, organizing and controlling workflow of clinical studies approved for implementation. Adheres to regulatory guidelines and ensures timely, complete and accurate reporting of sensitive and confidential patient information. Has regular contact with physicians, health care personnel and patients. Assists resident physicians with required scholarly activity (Institutional Review Board (IRB) submission, presentations, manuscripts).

Essential Functions:

• Works collaboratively with and/or assists physicians, residents and related healthcare providers in the planning, coordinating, implementation and completion of research studies, clinical studies and/or multi-center clinical trials, and other scholarly activities.
• Recruits and screens subjects for research studies. Collects baseline and follow up data from subjects. Checks for validity and accuracy of data ensuring compliance with quality assurance requirements and clinical relevance.
• Acts as a resource for researchers by providing literature searches, assistance in research design, coding and abstracting data, computer data entry, media production and IRB submission.
• Assists researchers in preparing presentations and publications, as well as, contributing authorship to portions of manuscripts.
• Ensures that research activities comply with safety, professional, organizational and federal standards and/or regulations.
• Coordinates research activities in designated area and ensures efficient use of time, equipment, personnel and other resources to achieve objectives.
• Instructs students and novice researchers in proper research techniques and procedures.
• Maintains a working knowledge of all research protocols. Transmits and distributes protocol information, including protocol amendments, to the Institutional Review Board (IRB), physicians and staff members. Serves as a senior non-medical resource for protocol and clinical research information.
• Adheres to all protocol requirements to ensure validity of clinical research patient data. Coordinates activities of clinical studies/trials and ensures adherence to the protocol by all personnel involved.
• Collects or ensures that all pertinent and required data is properly abstracted and recorded on data collection forms for each study subject.
• Creates and maintains patient database to ensure all data time points are captured. Designs and distributes materials which aid physicians and other staff members in complying with protocol requirements and patient enrollment.
• Meets regularly with principal investigators of studies to review data accuracy and overall study progress. Identifies areas for improvement and initiates corrective action.
• Prepares reports on individual patients as required by the study sponsor and/or the principal investigator. Prepares and/or processes adverse event reports on patients enrolled in studies and submits to the principal investigator, the IRB, study sponsors and appropriate agencies.
• Educates staff of affiliate departments as needed to conduct clinical trials and seeks to develop and maintain a working relationship with affiliates.
• Prepares for and participates in audits of studies, both by internal and external parties. In conjunction with the principal investigator, writes audit summary and reports and develops/coordinates corrective action plans as needed.
• Under the direction of the principal investigator, prepares new study requests and protocol consent modifications to be sent to the IRB. Prepares annual protocol renewal requests and termination reports for the principal investigator.

Common Expectations:

• Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research Clinical Operations, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to ensure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research Clinical Operations and the appropriate Service Line Leader.
• Provides outstanding service to all customers; fosters teamwork; and pract