[Hiring] Senior Clinical Research Associate @Medpace, Inc.

Role Description

Our activities in Latin America are expanding and Medpace is seeking to add Experienced CRAs to our growing team in Brazil! The Clinical Research Associate at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development. For those with medical and/or health/life science interest and background who want to explore the research field, travel throughout Brazil, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!

Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields.

PACE – MEDPACE CRA TRAINING PROGRAM

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.
• Develop your CRA skills through interactive discussions and hands-on job-related exercises and practicums.
• Participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.

UNEXPECTED REWARDS

This role 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.
• 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

• ***We kindly ask that you submit your application in English***
• Bachelor's degree in a health or science related field is required.
• 5+ years of experience in clinical monitoring or CRC experience preferred.
• Willingness to travel nationwide within Brazil.
• Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF and reconciling TMF documentation.
• Excellent verbal and written communication skills in Portuguese and English.

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.

Company Description

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.