Jobs in Leipzig, Germany

Primarily a training and development role, this position will support and observe clinical site monitoring services both in-house and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of clinical site monitoring services whilst providing monitoring and site management activities for full-service studies, assessing protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, and perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring, and close-out visits under supervision and/or independently, in accordance with corporate, sponsor, and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.

• Conducts and documents remote site contacts which could include remote site initiation, monitoring, and close-out visits. Documents activities per SOPs and study guidance.
• Conducts and documents onsite activities such as feasibility, qualification, initiation, monitoring, and close-out visits under supervision. Documents activities per SOPs and study guidance.
• Conduct remote data review of EDC, CTMS, RBM, and other clinical systems to ensure alignment with SOPs, study guidelines, and GCP best practices. Identify trends within and across study sites and escalate findings appropriately.
• Routinely reviews the site section of the TMF for accuracy, timeliness, and completeness. Requests new/updated documents from the site/primary assigned CRA, as required.
• Support CRA II, Senior CRA, and Lead CRA's in day-to-day study management activities.
• Remotely monitor, resolve, and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial.
• Coordinate delivery of clinical site communications, collaborating with project teams, to ensure investigational sites are provided with accurate ongoing data, updates, information, and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
• Support preparation for audits and required follow-up actions.

• Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools.
• Ensure SOPs are in place to optimize patient recruitment, providing guidance to site teams on inclusion/exclusion criteria.

• Successfully complete CRA development track activities and milestones.
• Develop and demonstrate competencies required to fulfill the role of a CRA.
• Support and observe primary assigned CRAs at both onsite and remote visits.
• Support Lead CRAs with remote site management activities.
• Participate in all study-related activities, including trainings, team meetings, and provide necessary updates to the study team.

• The successful candidate will possess a minimum of a college diploma/degree and 1-3 years related experience.
• SoCRA, CCRA, and/or ACRP certification/designation is an asset.
• The successful candidate must exhibit self-motivation, strong communication skills, and a commitment to achieving positive results.
• Strong attention to detail and a keenness to understand the importance of building collaborative relationships to achieve results.

• Home-based
• Regular travel

€39,500 - €66,000 a year