Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation
Supporting the development of a subject recruitment plan
Establishing regular lines of communication plus administering protocol and related study training to assigned sites
Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.
Qualifications
University degree in scientific discipline or healthcare
At least 1 year of on-site monitoring experience
Good knowledge of GCP and clinical research regulatory requirements
Good computer skills including MS Office
Excellent command of English language
Organizational, time management and problem-solving skills
Ability to establish and maintain effective working relationships with colleagues, managers, and customers.