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