Sr CRA (Level II)

Job Description

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Qualifications:

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

Bachelor's degree preferred.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.