Clinical Trials Assistant Sponsor-dedicated

Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

Trial and site administration and Document management:• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for completeness.• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

• Regulatory & Site Start-Up responsibilities: In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions, Obtain, track and update study insurance certificates, Support preparation of submission package for IRB/ERC and support regulatory agencies submissions, publish study results for GCTO and RA where required per local legislation

• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for: Develop country and site budgets, Tracking, and reporting of negotiations, Maintenance of tracking tools, Contract development, negotiation, approval and maintenance, Update and maintain contract templates (in cooperation with Legal Department), Payment calculation and execution (investigators, vendors, grants), Ensure compliance with financial procedures, Monitor and track adherence and disclosures, Budget closeout, Obtain and process FCPA documentation in a timely manner

• Meeting Planning: Organize meetings, Support local investigator meetings, Contributes strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

• Mentors / buddies junior CTCs on process requirements

Qualifications• B.A./B.S. (Life Science preferred) or equivalent healthcare experience• 1-3 years administrative support experience.• Equivalent combination of education, training and experience.• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.• Excellent written and verbal communication skills in Greek including good command of English language.• Effective time management and organizational skills.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.• Knowledge of applicable protocol requirements as provided in company training.

• Excellent negotiation skills for CTCs in finance area