Clinical Research Associate Responsibilities

The main function of a Clinical Research Associate (CRA) is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO) or for a pharmaceutical organization. A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators.

Clinical Research Associate serves as a primary contact with individual investigational sites that conduct clinical trials. cRA performs and coordinates all aspects of the clinical monitoring process in accordance with ICH GCP and FDA guidelines and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. He/She is responsible for ensuring that data will pass international quality assurance audits.
Performs site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.

CRA will
- Provides monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.  Escalates quality issues to Clinical Team Lead and/or Line Manager
- Manages the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.