DescriptionJob PurposeThe Clinical Research Associate (CRA) is part of Clinical Operations or Strategic Resourcing Solutions Unit within TFS Develop and will function operationally as a member of a Project Team and is responsible for the initiation, on site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements.
The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed : may involve overnight and international travel.
Key ResponsibilitiesMonitor on-site and remotely clinical trials in accordance with TFS and / or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelinesReview CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites / clients to resolve problem dataIdentify site problems / deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRAInitiates corrective action to resolve issues as directed by supervisorContribute to the completion of the application to Ethics Committee / IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA / Project ManagerParticipate in contract handling and negotiation directed by Lead CRA / Project ManagerSet up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
or equivalentMinimum 1-3 years of relevant clinical experienceAt least 1 year of experience in oncology therapeutical areaAble to work in a fast paced environment with changing prioritiesUnderstand basic medical terminology and science associated with the assigned drugs and therapeutic areasPossess the understanding of Good Clinical Practice regulations, ICH guidelinesAbility to work independently as well as in a team matrix organizationExcellent written and verbal communication skills.
Excellent organizational skillsAbility and willingness to travel up to 60-70%Job SummaryID : 0454D74C95Department : "SRS" Type : full time