Research Analyst

• Contributes to the selection of potential investigators and participates in National Investigators meetings as applicable.
• Accountable for study start-up and regulatory maintenance where required, including Site Qualification Visits and document submission to EC/IRB and Regulatory Authorities.
• Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms site staff training (including ICH-GCP) and ensures sites are inspection ready; assists site in maintaining inspection ready ISF.
• Initiates, monitors, and closes study sites in compliance with Client Procedural Documents; updates CTMS and other systems with study data.
• Manages study supplies, drug supplies and drug accountability at study site; prepares study drug for destruction if applicable.
• Performs monitoring visits (remote and onsite) and remote data checks per the Monitoring Plan; performs SDR, CRF review and SDV.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly.
• Ensures data query resolution and works with data management to ensure robust quality of collected study data.
• Ensures accurate and timely reporting of Serious Adverse Events and follow ups.
• Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to Principal Investigator, including follow-up letters.
• Follows up on outstanding actions with study sites and escalates study-related issues as appropriate; follows quality issue processes and escalates to Local Management/CQM when required.
• Prepares for and collaborates on audits and regulatory inspections in liaison with LSAD and CQAD; ensures timely collection/uploading of essential documents into the eTMF.
• Supports/participates in regular QC checks performed by LSAD or delegate and ensures documents are ready for final archiving.

Senior Clinical Research Associate

Senior Clinical Research Associate – Contract

Senior Clinical Research Associate I

Senior Clinical Research Associate – FSP