Clinical Research Associate - Entry (Home-based)

Medpace, Inc.; Malaysia; On-site; MYR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive pay

Health benefits

PTO benefits

Occasional WFH

Social events

Job summary

Medpace, Inc. in Malaysia is seeking a full-time Clinical Research Associate Entry to join our Clinical Monitoring team. No research experience is required as Medpace provides comprehensive training through the PACE CRA Training Program.

You will conduct site visits, verify documentation, and support regulatory compliance while traveling up to 60–80% nationally. A health/science background and strong communication skills are preferred.

Qualifications

• Bachelor’s degree in Health or Life Science related field preferred.
• At least 2 years of prior study coordinator experience is preferred.
• Willing to travel approximately 60-80% nationally.
• Familiarity with Microsoft Office; and
• Strong communication and presentation skills a plus.

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.

Skills

Interpersonal communication

Presentation skills

Willingness to travel

Team collaboration

Education

Bachelor’s degree in Health or Life Science

Tools

Microsoft Office

Job description

Job Summary

We are currently seeking a full-time, Clinical Research Associate Entry to join our Clinical Monitoring team in the Malaysia. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. For those with medical and/or health/life science interest and background who want to explore the research field and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!

PACE® – MEDPACE CRA TRAINING PROGRAM

No research experience is needed as Medpace 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

• Bachelor’s degree in Health or Life Science related field preferred;
• At least 2 years of prior study coordinator experience is preferred;
• 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) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.