Clinical Research Associate
Bristol-Myers Squibb is looking for a full time Clinical Site Monitor (CRA) to support the clinical trials within the Nordics region. R&D suppose a key point in our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases – the person working on this innovative development in the pharmaceutical industry could be you!
- Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders. Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
- Develops new sites, who have minimal research experience, by providing support in understanding the requirements to run clinical trials (i.e. SOPs, Training, Staff resources etc.)
- Conducts initiation visits in collaboration with other study team members and ancillary functional groups. Provides protocol specific and individualized training based on the Investigator and site personnel experience, prior to site activation
- Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, protocol, ICH/GCP Guidelines and other local regulations as applicable
- Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
- Performs site closure activities when all required protocol visits and follow-up are completed
- Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Ensures quality of data submitted from study sites and assures data currency by using the available systems to follow site activities.
- Motivates/influences the site to meet study objectives, including enrollment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
- Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
- Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
- Builds, cultivates and maintains customer relationships and identifies synergies between customer needs and the company’s interests
- Builds trusts with customers by serving as a consistent and accurate resource
- Bachelor’s degree in Science or similar
- 2 + year’s experience of working as a CRA within the pharmaceutical industry
- Demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions. Analyze root cause and potential bias. Seeks for appropriate input and creates a corrective and or / preventive action plan and communicate the process in a logical and timely manner
- Experience in using Microsoft suits, EDC and electronic Clinical Trial Management Systems.
- Has a thorough knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
- Possesses high communication skills and ability to work independently, prioritizing tasks and work in a matrix organization
- Experience in planning, preparing and submitting IRB document (not a must)
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to gender identity, race, colour, religion, sexual orientation, national origin or disability.