The Sr. CRA will have a broad knowledge and understanding of literature in their therapeutic area and broad knowledge of FDA/EMA regulations of clinical issues. The Sr. CRA will be able to design, plan and implement the overall direction of clinical research projects; will evaluate and analyze clinical data; coordinate activities of other internal staff and vendors; maintain a high level of professional expertise through familiarity with clinical literature and participate actively in project team meetings. Typically travels to field sites to supervise, monitor and coordinate clinical studies. This position may be responsible for the coordination of and assistance with protocol-related documents and other tools.
Specific responsibilities include, but are not limited to:
Assisting Clinical Operations Director in managing clinical trials, including:
ensuring appropriate documentation is in place to initiate trials
ensuring site is prepared for trial implementation
ensuring written procedures are followed and corrective action is taken if
Working effectively with investigators/coordinators, and developing familiarity with Axonics SNM System and data collection for study.
Creating documents required for clinical trial execution or overseeing the creation of applicable documentation/system tools.
Overseeing and assisting with the training of CRO clinical staff as applicable.
Assisting with the creation, inventory and complete QC of the Trial Master File for clinical trials.
Reviewing study data for completeness, accuracy, and appropriateness to study protocol and investigator’s Assisting in determination of patient validity.
Conducting, assisting or undertaking responsibility for the source document verification (SDV), monitoring and management of clinical trial sites.
Creating and completing monitoring plans and procedures, executing monitoring visits for applicable studies.
Arranging for the provision of device supplies, study materials, etc.
Acting as a liaison between Axonics and investigative sites as applicable.
Identifying and communicating potential issues or challenges regarding study conduct, safety issues or administrative processes.
Assisting with patient recruitment and enrollment processes.
Creating and implementing study issue logs and ensuring completion and implementation of issue escalation/resolution processes.
Developing clinical protocols in consultation with medical monitor and assisting with the design of specific case report forms and completion guidelines.
Assisting in site identification and qualification process for clinical trials.
Assisting in identification, selection, and audits of clinical trial vendors.
Other duties as assigned.
Adherence to the Axonics Code of Business Conduct & Ethics.
Minimum five years’ experience in clinical research with good knowledge of medical device clinical research.
Exercise independent judgment.
Ability to understand and discuss relevant clinical data.
Ability to establish strong communication with investigators, study coordinators, and other personnel.
Strong presentation skills, organization skills and attention to detail.
Broad knowledge and understanding of the design and critical review of clinical studies.
Planning ability in coordinating multiple tasks and ensuring their completion within specified timelines.
Problem-solving abilities in overseeing clinical studies.
Ability to demonstrate tactfulness and persuasiveness in dealing with study coordinators and other study personnel.
Utilize independent judgment in monitoring clinical studies and in determining methods and procedures on new assignments.
Ability to work well cross-functionally within the organization; communicate effectively with all other developmental departments: Engineering Operations, Quality, Global Marketing, Business Development, Finance, and Executive Management Team to ensure everyone is aware of status, issues, risks, timelines, etc.
Ability to work effectively in teams.
Excellent verbal and written communication skills required.
Willingness to travel up to 50%.
To apply for this position, please reference Job Code AXN-CLINOPSCRA and email resume/CV to: firstname.lastname@example.org. PLEASE NO RECRUITERS
Axonics Modulation Technologies, Inc. - a privately-held medical device company – has developed an innovative neuromodulation platform based on miniaturized rechargeable technology. The Axonics Sacral Neuromodulation (SNM) System™ is the first CE-marked rechargeable SNM system for the treatment of urinary and fecal dysfunction and the system’s user-centric design is expected to provide an enhanced user experience for both clinicians and patients.