Experienced Clinical Research Associate - (Home-based) at Medpace, Inc.

, , Malaysia -

Full Time

Start Date

Immediate

Expiry Date

02 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Monitoring, Communication, Presentation Skills, Regulatory Document Review, Data Verification, Patient Recruitment, Adverse Event Reporting, Medical Device Accountability, Research Documentation, Team Collaboration, Problem Solving, Time Management, Attention to Detail, Training, Therapeutic Knowledge, Good Documentation Practices

Industry

Pharmaceutical Manufacturing

Description

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 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.

Responsibilities

The Clinical Research Associate will conduct visits for research sites, ensuring compliance with protocols and regulations. Responsibilities include communication with site staff, data verification, and completion of monitoring reports.