CRA II

Overview

As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies, and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s, and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.

Responsibilities

What you will be doing:

1. Perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
2. Contribute to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e., operating manuals, monitoring guidelines, etc.);
3. Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the Project Manager.
4. Negotiate investigator budgets and assist with the execution of site contracts with support from the legal department.
5. Oversee all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.

Qualifications

You are:

1. Degree in Pharmacy or any related course.
2. 2 years prior monitoring experience with global trials.
3. Experience with clinical trial set up and contract negotiation preferred, but not essential.
4. Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of local regulations.
5. Good understanding of Clinical Study Management including monitoring, study drug handling and data management.