We have some great Clinical Research Associate roles for oncology CRAs. Ideally, you will be a Senior CRA with strong experience in early phase oncology. We can consider a CRA too for this work, potentially too. 

The Senior Clinical Research Associate (Sr. CRA) will be a key member of the team and will utilize their knowledge as a resource to help other CRAs develop their skills.

The Sr. CRA will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with our client or sponsor standard operating procedures (SOPs), monitoring plan (MP), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), regional specific regulatory requirements, ensuring study completion on time and within budget.

You may be called upon to interact independently with sponsors involved in their projects, and to assist in some relevant departmental tasks and initiatives. The Sr. CRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project.

The degree of responsibility given to a Sr. CRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.

This position will focus on the on site monitoring of Early Phase Oncology trials (Phase I-II).

Duties include but are not limited to:

? Serve as the primary point of contact for investigative sites.

? Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and region specific requirements

? Serve as a mentor within the organization, working with others to help them organize their time efficiently.

? Has in-depth knowledge of ICH GCP and region specific regulations and begins to give guidance to junior CRAs on applying this knowledge to the practice of monitoring.

? May perform CRA assessment and training visits per SOPs.

? Assist in the development and delivery of departmental trainings.

? Able to give practical guidance on application of systems, processes, and regulations.

? Actively participate in training sessions and workshops, including presenting reports from any conferences attended.

? May be involved in bid defense meetings, kickoff meetings and other sponsor presentations.

? Ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood. Serve as a subject matter expert (SME) within Development Innovations standards.

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