Cardiovascular Clinical Research Coordinator

Job Description

Position Summary

The position of Cardiovascular Clinical Research Coordinator facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. Responsibilities Include: Promotes the ethical conduct of research. Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Schedules research subject appointments and serves as the patient liaison to the PI and other participating physicians. Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections. Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process. Coordinates and attends (SIV) site initiation visits, monitor visits, study termination visits. Completes case report forms in timely manner. Extracts data from research subject charts in a timely manner. Coordinates the completion of all protocol required forms by the investigator during study visits. Responds to data clarification requests in a timely manner. May attend investigator meetings in person or remote and report pertinent information back to research team members. Coordinates with investigators to help ensure that clinical research and related activities are performed in accordance with Federal regulations, sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around tasks related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training. Maintains weekly subject screening logs. Promptly report protocol deviations to sponsor/regulatory coordinator(s). Assess whether protocol deviations meet IRB requirements for promptly reportable information with regulatory coordinator(s). Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors. Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. Cooperates with sponsor on compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. Properly documents study visit tasks in the form of a research note. Ensures that all materials for each clinical trial protocol are available for subject enrollment. Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data. Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Establishes and organizes study files, study specific source documentation and other materials as required. Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, sponsors, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures. Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer. May perform other job-related duties as requested or required. Ability to perform intramuscular injections, venipuncture, peripheral intravenous lines, collect biological specimens and administer medications via all routes. Use of standard patient care equipment such as 12-lead ECG, pulse oximeter, blood pressure monitor, thermometer, IV pumps, & centrifuge. Knowledge of medications, indications, dosage ranges, side effects, and potential toxicity. Job Type: Full-time Salary: $37.00 - $45.00 per hour