Remote Lead CRA

Job Description

Coordinates and oversees all clinical aspects on a study for assigned sites from start-up to close-out, as applicable per study specifications and as defined in CRG SOPs and Task Matrix. Colleague is an expert in remote monitoring. Performs remote site monitoring activities and reviews subject data on an ongoing basis in line with CRG and/or Client procedures. To ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs and to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with client company personnel and investigational sites. Contacts study sites to discuss study status, monitoring findings and issues and requests outstanding information and documentation. Triggers on-site monitoring indicating areas of focus, in order to guarantee that pertinent tasks and identified findings are addressed. Plays an active role within the clinical team to reach clinical goals, achieve deliverables and meet project deadlines. Regularly coaches and mentors colleagues within scope of expertise.

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.