Experienced Clinical Research Associate - (Home-based)

Medpace
Malaysia
MYR 100,000 - 150,000
Job description

Job Summary

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;
  • Communicate with the medical site staff including coordinators, clinical research physicians, and their site staff;
  • Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff;
  • Verify medical record and research source documentation 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;
  • Ensure that the investigator is enrolling only eligible subjects;
  • Review regulatory documents;
  • Manage medical device and/or investigational product/drug accountability and inventory;
  • Review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  • Assess the clinical research site’s patient recruitment and retention success and offer suggestions for improvement;
  • Complete monitoring reports and follow-up letters, which include 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;
  • 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.

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