Clinical Research Associate/ Senior Clinical Research Associate Job in Aurigene Discovery Technologies Limited

Desired Profile

M. Pharm / M.Sc. with 1 - 10 years of experience

Job Description, Key Skills and Competencies:

Perform site selection, monitor and ensure trial close out and retrieval of trial materials. Work with sites to adapt, selection, initiate drive and track subject recruitment plans. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Create and maintain appropriate documentation related to site management, monitoring visit findings and action plans. 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 protocol and adherence to applicable regulations. Manage the progress of assigned studies by tracking regulatory submissions & approvals, recruitment & enrolment, case report form (CRF) completion & submission, and data query generation & resolution. Responds to company, client and federal regulatory requirements / audits under supervision of Project Manager. Collaborate and liaise with study team members for project execution support. Maintain and keep administrative tasks (such as expense reports) updated. Assist project team to prepare project publications / tools and share ideas/suggestions with team members. Perform additional study tasks as assigned by the Project Manager (e.g. visit report review, CRA performance review, lead CRA calls etc.). Require effective clinical monitoring skills. Knowledge of ICH-GCP, Schedule Y guidelines and other regulatory guidelines. Understanding and demonstrated application of GCPs and applicable SOPs Competencies: Communication Skills Interpersonal Skills Team Player