Experienced Clinical Research Associate - (Home-based)

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

Job summary

A leading clinical contract research organization in Malaysia is seeking a Clinical Research Associate (CRA) to join their PACE® training program. This role entails conducting site visits, communication with medical staff, and ensuring compliance with regulations. The ideal candidate will have a bachelor's degree in a health or life science field and 1.5 to 5 years of clinical monitoring experience. Enjoy a dynamic work environment and significant travel opportunities along with competitive pay and benefits.

Benefits

Flexible work environment

Competitive compensation and benefits package

Structured career paths

Employee health and wellness initiatives

Qualifications

• Minimum of 1.5 to 5 years of experience in clinical monitoring.
• Willing to travel approximately 60-80% nationally.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits for research sites.
• Communicate with medical site staff, including clinical research coordinators and physicians.
• Verify investigator qualifications and training, including facilities and staff adequacy.
• Ensure accurate documentation practices are being adhered to.
• Verify that the investigator is enrolling only eligible subjects.
• Conduct regulatory document review and medical device accountability.
• Review adverse events and ensure accurate data reporting.

Skills

Communication skills

Presentation skills

Microsoft Office familiarity

Education

Bachelor's degree in health or life science

Job description

PACE® – MEDPACE CRA TRAINING PROGRAM

PEACE® provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence:

• PACE® provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
• PACE® will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums.
• To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.

UNEXPECTED REWARDS

This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including:

• Dynamic working environment, with varying responsibilities day-to-day
• Expansive experience in multiple therapeutic areas
• Work within a team of therapeutic and regulatory experts
• Defined CRA promotion and growth ladder with potential for mentoring and management advancements
• Competitive pay and opportunity for significant travel bonus

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Minimum of a bachelor’s degree; Health or life science related field preferred;
• At least 1.5 to 5 years of experience in clinical monitoring;
• Willing to travel approximately 60-80% nationally;
• Familiarity with Microsoft® Office; and
• Strong communication and presentation skills a plus.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.