This individual will be responsible for monitoring and site management activities for Phase I-IV device/drug clinical projects.

·        Perform all types of site visits –qualification, initiation, interim monitoring and close out, ensuring the site is doing the right thing in compliance with regulations, ICH-GCP, the monitoring plan and protocol.

·        Conduct source document review and verify accuracy of data entered in the CRF

·        Work with and serve as the site primary point of contact

·        Provide training on the protocol,study procedures, EDC and any other study specific requirements to site staff

·        Perform regulatory document management/review and reconciliation between the ISF and TMF

·        Contribute to study document creation and review

Minimum of 2 years field monitoring experience with 5 years overall clinical research experience. Thorough understanding of current ICH/GCP and FDA regulations pertaining to clinical research.

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Education‍

Bachelor’s Degree, ideally in a scientific or healthcare field, a healthcare certification, or an equivalent combination of education,training, and experience.

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This job is right for you if:

·        You work smart and hard. You have high standards and you deliver value consistently by being inquisitive, innovative and working with intent.

·        You can juggle and manage multiple priorities and projects,staying organized and always keeping a focus on quality.

·        You can travel regularly.

·        You love to get into the details and insist on accuracy in all you do.

·        You are a great communicator, where clarity and articulation of thought is important in both written and verbal communication

·        You embrace that speed of execution is a weapon for a growth company

·        You enjoy working with people, forging relationships, even through difficult conversations

·        You are proactive and anticipate needs and requests even before anyone asks.