Clinical Research Associate

ICON; Malaysia; On-site; MYR 100,000 - 150,000; Full time

Job summary

ICON, a leading clinical research organization, seeks a Clinical Research Associate in Malaysia. This role involves managing clinical trial activities, from site selection to monitoring and ensuring compliance with guidelines. Join ICON for a culture of inclusion and opportunity to thrive in a dynamic environment.

Qualifications

• 1+ years prior monitoring experience with global trials.
• Excellent knowledge of international guidelines ICH-GCP.
• Good understanding of local regulations.

Responsibilities

• Perform CRA duties from site selection to close-out visits.
• Contributes to Case Report Form design and clinical trial document development.
• Negotiate investigator budgets and oversee site management.

Skills

Monitoring

Data management

Clinical Study Management

Negotiation

Education

Degree in Pharmacy or related course

Job description

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 a well-known global pharmaceutical company with a strong portfolio in cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

• 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.
• Contributes 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.);
• 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.
• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department.
• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.

You are:

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

Why ICON?

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.