Strona główna

• To provide technical support for planning, conducting and documenting all project – related activities within office and/or laboratory parts of the department;
• Archiving all project-related documents;
• Responsible for working in accordance to actual regulatory guidelines and internal SOPs.

• Training of new CRC and/or CRA employee;
• Assigning tasks to CRC or CRA;
• Supervising CRC activities;
• Documenting his/her activities using MICS QMS forms;
• Preparing the study specific documentation (laboratory manual, project specific instructions, reference values lists, etc.);
• Conducting CTLMS-LIS project specific validation;
• Documenting sample and data discrepancies;
• Collection of source data from testing labs;
• Performs sample quality assessment;
• Reports delivery to clients/sites;
• Completion of the internal trackers;
• Formal checking of analytical results;
• Documenting sample errors (DCFs, NTFs, Rejection Notes, Phone call notes) and all actions during the study and adding appropriate documents into the study files;
• Documenting all changes to client in a timely manner (ex. NTFs for legal holidays, changes which occur during the study, etc.);
• Preparing archiving documents;
• To provide support for the APM functions if needs;  
• To approve the laboratory results report (formal and essential approval);
• To contact with investigator;
• Formal checking of project reference values list;
• Participation to SIVs if asked;
• Data cleaning;
• To assist the APM in the coordination of supplies for each clinical study;
• To coordinate all logical aspects of the project;
• Shipment/packages quality assessment;
• Tracking of kits expiration at study sites;
• Performing kits quality control;
• Coordination of study samples partially tested to other labs (affiliate, subcontracted, etc);
• Perform materials/shipment packages quality assessment;
• Completion of all MICS forms related to logistic issues;
• Sampling kit design;
• Planning, conducting and documenting all study related logistics;
• To coordinate all laboratory activities regarding the project;
• To supervise preparation and assembly of lab shipments;  
• Registration the samples into LIS/CTLMS;             
• Maintaining and developing study related relationships with subcontracted labs and vendors;
• Ensure that all laboratory results will be sent of properly.

Education:

• Master degree, preferable – Medical or Biological; at least 2 years experiences as a Clinical Research Assistant related experience preferred or similar role;
• Must possess excellent organizational an interpersonal skills.

• English – communicative, other languages preferable;
• Ability to read and interpret documents, write routine reports and Correspondence.

• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, circumference, and volume;
• Ability to apply concepts of basic algebra and geometry.

• Ability to apply common sense understanding to carry out instruction furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.     

• To perform this job successfully, an individual should have a ‘better than’ working knowledge of Microsoft Office applications including MS Word, Excel, and PowerPoint.

• Full-time job;
• Hybrid-work;
• Contract of employment;
• Work flexible hours;
• Medical Care;
• Multisport Card;
• Private insurance.