Primary Responsibilities:

 Perform site selection (if applicable), initiation, monitoring and close-out

visits in accordance with contracted scope of work, SOPs (and / or the

Sponsor’s SOPs as appropriate) and the ICH GCP and associated regulations.

May perform co-monitoring visits and other types of site visits as needed.

 Support development of project subject recruitment plan on a per site basis.

Work with sites to adapt, drive and track subject recruitment plan to meet

project recruitment target.

 Administer protocol and related study training to assigned sites and establish

regular lines of communication with sites, ensure that study milestones for

sites responsible are met as planned with high quality (i.e., study startup,

recruitment, database lock, closeout, etc.)

 Create and maintain appropriate documentation regarding site management,

monitoring visit activities by submitting regular visit reports and/or other

required study documentation.

 Evaluate the quality and integrity of study site practices related to the proper

conduct of the protocol and adherence to applicable regulations. Take

corrective action and preventative actions to mitigate the risk. Escalate quality

issues as appropriate.

 Manage the daily progress of assigned studies by tracking regulatory

submissions and approvals, recruitment and enrollment, case report form

(CRF) completion and submission, Ethics Committee documents submissions

and approvals, study drug management, document filing, site payments, data

query generation and resolution. May support start-up phase and additional

site-self assessment requirements.

 Collaborate and liaise with study team members for other project execution

support as appropriate.

 Performs additional task as assigned by line manager.

 May be assigned as the mentor of less experienced CRAs

 Other activities/tasks assigned by supervisors.