Sr.CRA Freelance / Contractor for 0.5 FTE in Romania in Oradea

Description SR . CRA - Freelancer / Contractor 0.5 FTE in the beginning Sponsor Dedicated, Based in Romania Job responsibilities • Perform monitoring visits according to plan, document actions and follow up on action plans • Site feasibility visits including analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies • Train and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs) • Train site staff in safety information handling and systems • Know and meet all local and company requirements with respect to safety reporting • Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team • Identify potential risks and proactively take action to prevent or mitigate • Collaborate with data management/logistics in resolving queries • Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan • Manage trial product requirements, including temperature deviations and training of site staff • Motivate and build strong relations with site personnel to ensure the sponsor is their preferred clinical research partner • Ensure collaboration with and deliverables from vendors locally, if applicable • Collection and management of essential documents • Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF) • Participation in Investigators meetings to ensure relations with sites as well as active presentation as applicable Qualifications What we’re looking for Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience 3 years or more of clinical monitoring experience as a CRA Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Fluency in English Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis #LI-KU1