Freelance Senior Clinical Research Associate

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Freelance Senior Clinical Research Associate (0.35 FTE) - home based in Hungary. Interested in future opportunities with TFS HealthScience ? We are currently building a network of experienced Freelance Senior Clinical Research Associates for an anticipated ophthalmology project. While this position is not yet actively open for immediate recruitment / onboarding, we encourage interested candidates to apply and join our talent community. Once sponsor requirements are confirmed, our Talent Acquisition Team we will reach out to candidates whose experience best aligns with the project needs. About this role As part of our Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Freelance Senior Clinical Research Associate is part of Clinical Development Services (CDS) within TFS HealthScience , will function operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and regulatory requirements. The Freelance Senior Clinical Research Associate will provide Unmasked Clinical Research Associate support for assigned clinical studies, including management of investigational product accountability, oversight of unblinded site activities, and monitoring of protocol compliance in accordance with study requirements and applicable regulations. The Freelance Senior Clinical Research Associate will collaborate with study teams, investigative sites and sponsors to ensure timely execution of study deliverables while maintaining the integrity of study blinding and data quality. Key Responsibilities: - Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality. - Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations. - Review CRFs (electronic or paper) and subject source documentation for validity and accuracy - Verify proper management and accountability of Investigational Product - Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate. - Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner. - Timely delivering site documents to eTMF or paper TMF. - Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements. - Update CTMS and all other required by projects systems with accurate site level information - Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed. - Order, ship, and reconcile clinical investigative supplies for study sites, if applicable. - May assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include: - project tracking, - monitoring plans, - Review of monitoring reports - CRA resources management within the project - May perform Assessment Site Visits (ASV) when requested. - May act as a mentor to CRAs. - May develop and implement therapeutic area training for other