Job am 09.03.2025 bei Jobleads gefunden
Senior Clinical Research Associate
• München, Bayern
[...] Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials, as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and
quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/ issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in setup/ collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as
referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF
data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/ TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/ GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/ Sponsor SOPs. Participates in internal, client/ sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/ CTC and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for [...]
