Sr.CRA Freelance / Contractor for 0.5 FTE in Romania
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
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