18 oct
|
OneSeven Technology (formerly 17 Web Dev)
|
Mendoza
18 oct
OneSeven Technology (formerly 17 Web Dev)
Mendoza
Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.In this role you will:- Act as the main line of communication between the Sponsor or CRO and the site.- Ensure response to feasibility questions are provided in due time.- Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.- Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.- Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.- Maintain study specific and general tracking of documents at the site level.- Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.- Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.- Proper handling, accountability and reconciliation of investigational products and clinical supplies.- Collect,
handle and maintain all site-specific regulatory documents as needed.- Facilitate and support the contract and budget negotiations at the site level.- Support Investigator and Site payments and processes as needed.- Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.- Prepare for and participate in onsite study audits or regulatory agency inspections.- Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).Qualifications- College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.- Minimum of 3 years of on-the-job experience in a clinical trial environment, where relevant experience has been gained in clinical trials, clinical terminology, and medical research working in the role of a Study Coordinator or similar function.- Upper-Intermediate level of English, with the ability to work in a general team environment.- Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.- Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.- Strong interest in professional growth and development within the company.Additional InformationIf you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!#J-18808-Ljbffr
📌 Remote Latam Clinical Monitoring Lead - Rbm & Analytics (Mendoza)
🏢 OneSeven Technology (formerly 17 Web Dev)
📍 Mendoza