Senior Clinical Research Associate

Proclinical has partnered with a world leading pharmaceutical organisation in search for a talented Senior Clinical Research Associate to perform monitoring and site management activities for Phase I-IV clinical research projects and assess the progress of clinical projects. This role is based in Germany and gives you an opportunity to establish your Clinical career.

Job Responsibilities

• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomised information related to IP.
• Applies knowledge of GCP/local regulations and organisational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF).
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication Understands project scope, budgets, and timelines for own and others' activities in the clinical team
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned.
• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection
• As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff
• The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.
• Identify operational efficiencies and process improvements
• Develop study and country level informed consent forms
• Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared

Skills and Requirements

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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