Clinical Research Associate-FSP

Site Management Responsibilities: 

• Contributes to the selection of potential investigators. 

• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. 

• Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. 

• Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. 

• Actively participates in Local Study Team (LST) meetings. 

• Contributes to National Investigators meetings, as applicable. 

• Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. 

• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. 

• Updates CTMS and other systems with data from study sites as per required timelines. 

• Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. 

• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. 

• Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. 

• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. 

• Ensures data query resolution in a timely manner. 

• Works with data management to ensure robust quality of the collected study data. 

• Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. 

• Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. 

• Follows up on outstanding actions with study sites to ensure resolution in a timely manner. 

• Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. 

• Assists site in maintaining inspection ready ISF. 

• Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). 

• Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. 

• Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. 

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. 

• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.