Clinical Research Associate
Job Description
Perform monitoring and site management work to ensure that sites are conducting the studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: Perform site monitoring visits (selection, initiation, monitoring and close-out 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 to enhance predictability. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Requirement(s)
Bachelor's Degree Degree in scientific discipline or health care preferred. Req Requires at least 2 years of year of on-site monitoring experience. Req Equivalent combination of education, training and experience may be accepted in lieu of degree. Req Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
