Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol.
Perform site monitoring visits in accordance with contracted scope of work and Good Clinical Practice.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.
Administer protocol and related study training to assigned sites and establish regular lines of communication.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission.
Ensure copies/originals site documents are available for filing in the Trial Master File.

Bachelor's Degree in scientific discipline or health care preferred.
Requires at least 2 years of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
Good therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Clinical Research Associate, Oncology

Key skills