Engage in company training program to gain knowledge and skills required to independently conduct clinical remote monitoring visits and other clinical research activities in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Gain an understanding of all aspects of Real World Late Phase Research (RWLPR) site management and monitoring by striving to understand the work based on a combination of structured training programs, self-directed use of training materials and experience from study assignments.
· Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
· Gain experience with standard Quintiles tools, metrics and reports.
· Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites
· Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
· Under close supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions.
· Under close supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
· Under close supervision, 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 to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
· Under close supervision, manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
· Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.