Experienced Clinical Research Associate - (Home-based)

Job Title: Experienced Clinical Research Associate - (Home-based)

Job Location: UNAVAILABLE, Malaysia

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:

We are currently seeking a full-time, experienced Clinical Research Associate 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. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.

Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.

Through our PACE ® Training Program, you will join other Professionals Achieving CRA Excellence and receive customized, expedited training, and efficient onboarding to familiarize experienced CRAs with Medpace systems.

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 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) 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