Clinical Research Associate I - Center for Interventional Cardiovascular Research and Clinical Trials

About This Role

Monitoring all aspects of clinical research trials across their entire lifecycle is the core of this role, from site management to ongoing maintenance and closure of pre-clinical, Phase I through Phase IV, and post-marketing studies. The role suits a Clinical Research Associate I who can prepare and complete critical study documents, monitor resources, and manage clinical study documentation.

Responsibilities

• Prepare and complete critical study documents and perform final editing/proofing prior to publishing (e.g., protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.)
• Monitor resources/reports to deliver milestones on time and budget
• Collect, review and file all clinical study documentation for assigned trial(s) and investigative sites and maintain the clinical trial master file (CTMF), assuring all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs
• Participate, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM
• Work with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF)
• Prepare, collect and archive all study related correspondence to the investigator site including, but not limited to, newsletters, Dear Dr. letters, FDA/HA correspondence, contractual agreements and others
• Be responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval
• Collect pre-study documentation and essential regulatory documents from assigned investigator sites, as well as, collect updated documents prior to study initiation and on an ongoing basis
• Estimate, order and coordinate shipments of clinical study supplies to assigned investigator sites
• Assist the CTM with tracking and requesting grant payments, and maintain the study budget
• Track and report all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicate with assigned sites on routine matters
• Review all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable
• Report safety findings in a summary format to the CTM
• Prepare documentation for and attend Clinical Event Committee (CEC) meetings, if applicable
• Identify and document data errors or items requiring clarification on all documents collected for study and initiate data clarification/validation process after researching source documents