Ref #: 33599

Employment type: Permanent - Full-Time

Location: Hungary Budapest

Posted: 09-Nov-2021


Site administrating and site monitoring responsibility for clinical studies according to NN Standard Operating Procedures, ICH Guidelines and GCP;
• To ensure all trial related activities within agreed timelines
• To manage recruitment and retention strategy on site and country level
• To perform site selection visits, routine monitoring visits and closure visits in accordance with country mail stones and protocol requirements
• To coordinate relationships and co-operation between local study team
• To establish co-operation with investigators and other site staff, including e-learnings and study related trainings, compliance with protocol procedures, protocol deviations process and essential trial documents maintaining
• To communicate with global study team (CPM) in scope of trial related activities and requirements
• To ensure co-operation with trial vendors
• To establish co-operation with other CMR colleagues, marketing and sales departments of NN
• To ensure compliance with the trial budget and perform relevant changes during ClinCost process according to R&D financial calendar;
• To ensure compliance with Novo Nordisk corporate policies/procedures and behavior and following ‘team spirit’ in collaboration with all other members of the organization
• The CRA is responsible for conduction of delegated trial(s) in affiliate and may act as a Country Responsible Monitor

Key areas of responsibility:

The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company.

The CRA works with documentation at the initial stage of the project. Arranges insurance for patients. Purchases necessary study related materials if applicable for local study conduction purposes.

The CRA is responsible for taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, NN procedures and protocol requirements to ensure data quality and study subject protection. The CRA is as such responsible for recruitment at site level. The CRA thereby delivers results that have a direct impact on the successful completion of the clinical programme.

The CRA coordinates with CPM and CTM and communicates to them progress and critical issues that may impair trial progress. In some cases, the CRA may have direct contact with the ITM. CRA may also act as a Country Responsible Monitor.

The CRA responsibilities in site management include:
• Efficient and accurate site selection visits (as appropriate including analysis of site logistics, site performance/quality indicators)
• Accountability for patient recruitment strategies, including implementation of mitigation actions
• Has good knowledge of trial product and trial protocol and train site staff in trial procedures, handling of trial product and documents
• Visit trial sites regularly in accordance with the protocol to perform monitoring activities required
• Proactive use of IT Systems (e.g. IMPACT, EDC) for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
• Guide site staff in preventing deviations that will compromise integrity and quality of trial-conduct
• Train site staff in safety information handling and systems
• Meet all local and company requirement with respect to safety reporting
• Collaborate with Data Management in resolving queries
• Manage trial product requirements incl. temperature deviations incl. training of site staff
• Motivate and build strong relations with site personnel to ensure NN is their preferred provider
• Ensure collaboration with and deliveries from vendors locally
• Ensure that the documents are timely collected and in compliance with NN SOP and regulatory requirements
• Attendance at Investigators Meetings and Monitors Meetings to ensure relations with sites as well as active participation
• Quality responsible person at the site

The CRA responsibilities in local trial management include:
• Overall trial organisation and coordination within the country
• Ensure timely and accurate communication of trial issues and function as key point of contact for CRAs and CPM (if applicable)
• Ensure compliance with the application and communication of all Novo Nordisk policies, essentials and procedures.
• Accountable for all project timelines and deliverables within the country
• Accountable for the country budget according to ClinCost procedures
• Provide consolidated country input for review of key documents (e.g. protocol and related documents)
• Consolidate systems and vendor input per country as applicable (e.g. CRF and diary)
• Ensure timely applications, response to questions and approvals for EC/HA and IRB/IEC
• Ensure update of IMPACT at trial country level
• Ensure approval of local IMP label and coordinate handling of trial products as applicable
• Prepare the country recruitment and mitigation plan incl. consolidating the CRA site plans
• Monitor recruitment and retention of trial subjects and take appropriate actions according to the agreed country plan
• Provide trial status update and other reports or feedback as required to CPM
• Ensure data cleaning milestones and DBL deliverables according to the Data Flow Plan
• Ensure review, approval and follow-up of monitoring visit reports incl. protocol deviations
• Ensure filing and archiving of trial related documents in the Trial Master File at the country level
• Ensure compliance with GCP, ICH and local regulations
• Initiate and drive contracts with sites as per local practise

Additional responsibilities:
• Timeliness in deliveries through process planning and goal setting
• Identify potential risks and proactively take action to prevent and as needed, mitigate
• Adeptness in ALL trial management-related IT systems (e.g. EDC, IVRS, FIRECREST, GHN, etc…)
• Therapeutic knowledge and general understanding of diseases and treatments
• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
• Support audit and inspections at sites as applicable
• Proficient use of NN systems (e.g. IMPACT, CATS)
• Perform/review/correct translation of trial related documents