Senior Clinical Research Associate till TFS AB

To work as an Senior CRS at TFS Trial Form Support AB is to be a member of the Study Team when applicable, and be responsible for the initiation, monitoring and termination of tasks during the study process, according to company policies, SOP's and regulatory requirements.The position is full-time and you will be located at our office in Lund, Sweden. The main responsibilities of the Senior CRA will include: .The S-CRA should act as the main communication link between TFS/Sponsor and the study sites for activities related to site management..The S-CRA is responsible for the site management of the study, i.e.site visits, monitoring, document filing, telephone contacts, and correspondence.The monitoring process should be performed in accordance with ICH-GCP, the SOPs of either TFS or the Sponsor and relevant legislation..The S-CRA is responsible for preparing the sites for, and participating in, audits and inspections..The S-CRA will also take on responsibilities for training of CRAs and coordination of CRA activities, site identification / evaluation, and sponsor contact duties that a Clinical Research Manager (CRM) usually is responsible for..The S-CRA may also be involved in the study protocol development, and give presentations at e.g.Investigator Meetings..The S-CRA may also in cooperation with/under supervision of the o Data Manager enter and proof-read data.o Safety Manager code adverse events, concomitant medication and concurrent diseases o Clinical Research Manager perform any CRM activities..The S-CRA is normally based at the TFS office, but may also work from the office of the Client if requested.Other requirements/qualifications: .University education in Medicine, Pharmacy, or Life Science corresponding to at least 80 points (2 years full-time education), or relevant experience..Education in Clinical research corresponding to training courses given by the Swedish Academy of Pharmaceutical Sciences: o Basic course in clinical trials (incl.GCP) o Supplementary course in clinical trials (incl.GCP) o Course in statistics in a clinical trial .At least 3 years experience as CRA including all steps of the clinical study; i.e.site initiation, site monitoring and site closure..Furthermore have experience from coordination / training of CRAs..Skills in written and spoken English .Good communication skills For more information about principal duties for a sCRA, see our homepage www.trialformsupport.com We are looking forward to receiving your application with included CV and a personal letter.