ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
· With support of Director, manage clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)
· Manage trial start-up, conduct, and close-out activities according to industry and corporate standards with Director support
· Assist with preparation of key clinical documents (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, annual reports, etc.)
· Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track
· Track internal metrics, timelines and budgets
· Communicate trial status to trial team
· Prepare and present trial specific updates to Director, Program Managers and Senior Management
· Participate in monitoring activities at clinical trial sites to assure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and ensure that data is complete and accurate
· In conjunction with data management personnel, gain understanding of planning, monitoring, and executing data analyses
· Support applications and technical files as needed
· Collaborate with project specific committees (e.g., DSMB, CEC)
· Assist with preparation for investigators’ meetings
· Work with vendors as needed
· Travel up to 50% of the time or as needed based on project deliverables
· Perform other TransMedics tasks and duties as required
REQUIREMENTS:
· 5+ years experience as Research Associate, Clinical Trial Assistant, Clinical Trial Coordinator, CRA or equivalent combination of education and experience
· Experience coordinating external and internal documentation for clinical trials
· Experience interacting with sites, monitors, IRB’s, sponsors, vendors, clinical centers, and FDA
· Experience screening and recruiting patients for studies
· Knowledge of adverse event investigation, analysis and reporting procedures and standards
· Proficiency with electronic data management systems
· Familiarity with clinical budget planning and management
· Basic understanding of data collection methodologies
· Familiarity with GCP, ICH, ISO and FDA regulatory requirements
· Experience in coordinating multi-center global clinical trials
· Ability to build collaborative relationships both internally and externally
· Willing to be held accountable for deliverables
· Must be highly organized and detail oriented
· Proven ability to handle multiple projects and changing priorities
· Must be results-driven and exhibit a sense of urgency
· Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
· Strong initiative and positive attitude
EDUCATION:
· BA/BS in Science, Life Sciences or relevant field; or eqiuvalent combination of education and experience