CLINICAL TRIAL ASSISTANT

The Clinical Trial Assistant is responsible for providing operational and administrative support for the day-to-day execution of clinical trials following established SOPs GCP and applicable regulatory requirements during the conduction of all activities proactively identifying and resolving operational project issues and participating in process improvement initiatives as required.
Supports the Study Team in operational activities to facilitate the achievement of quality objectives fulfilling specific projects timing.
Some of what youll be doing.
Serveas the main point of communication between Sponsor and OPIS team members to collect and provide information relevant to the delegated activities for a specific project; Organizeperiodic meetings with the study team to share and coordinate project activities to prevent criticalities and to facilitate communication among the concerned parties; Supportthe Project Manager in the creation/review/finalization of study newsletters presentations drafts of study-specific plans (TMF Plan Clinical Monitoring Plan Project Management Plan etc.) manuals and supportive materials; Responsible for collecting high level trial information to create/update project-specific status reports/trackers (i.
Progress Report enrolment curve patient status KPIs and/or metrics for any other indicator defined during the study risk assessment etc.) any other tracker requested by the Sponsor) cooperating with Sponsor and OPIS study team during files/tools development setting and maintaining; Initiate effective study communication with vendors sponsors and internal staff to support study timeline execution and to mitigate issues should they arise; Providesupport in daily management of Study Vendor(s) including tracking of payments; Supportthe Project Team in collecting and sharing with eTMF Assistant eTMF Specialist or Documentation Assistant allocated on the trial the study documentation to be filed in eTMF/pTMF and to maintain the project server folder / study Sharepoint updated; Provideassistance in managing the periodic eTMF/pTMF check in good coordination with the Documents Owners to evaluate quality and completeness status of trial documentation; What were looking for.
Degree preferably in Scientific/Life Science field; Able to work independently guaranteeing the security of information; Good Knowledge of English (written and speaking); Good knowledge and experience with Microsoft Office; Communication skills; Ability to multitask prioritize work and meet deadlines; Ability to work independently and as part of a team guaranteeing the security of information.
What we offer.
We offer a competitive salary bonuses and other benefits together with the opportunity to develop your professional career with an expanding and growing international company.
Please read the information notice on the processing of personal data in the candidates information section of our company website.
Who we are.
OPIS is an International CRO with 25 years of experience in conducting Phase I-IV non-interventional and medical devices studies on an international level.
We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials taking care of the Sponsor beyond the therapeutic area offering also accurate clinical investigations for medical and diagnostic devices.
With Global Clinical Research Locations all over the world OPIS offers a full range of integrated clinical research services as scientific advice medical writing trial start-up monitoring study management data management statistics pharmacovigilance medical monitoring electronic data capture as well as quality assurance and training.
Candidate Privacy Policy Required Experience.
Junior IC