Experienced Clinical Research Associate (CRA)

Medpace; São Paulo; Presencial; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

An established industry player is seeking Experienced Clinical Research Associates to join their dynamic team in Brazil. This exciting role offers a unique opportunity to engage in the research of drug and medical device development, with a focus on enhancing patient care. The position promises a vibrant work environment with diverse responsibilities, extensive training, and significant travel opportunities. Join a team of experts dedicated to bringing innovative pharmaceuticals to market while enjoying competitive compensation and numerous perks. If you're passionate about making a difference in healthcare, this could be the ideal opportunity for you.

Serviços

On-site fitness center(s)

Campus walking paths

Company-sponsored social and wellness events

Hybrid work-from-home options

Free and covered parking

Discounts for local businesses

Qualificações

• 2-5 years of experience in clinical monitoring preferred.
• Excellent verbal and written communication skills in Portuguese and English.

Responsabilidades

• Conduct qualification, initiation, monitoring, and closeout visits for research sites.
• Verify investigator qualifications and ensure compliance with protocols.
• Complete monitoring reports and follow-up letters.

Conhecimentos

Clinical Monitoring

Patient Management

Communication Skills

Protocol Knowledge

Regulatory Compliance

Formação académica

Bachelor's degree in health or science

Descrição da oferta de emprego

Job Summary

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.
• 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 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;
• 2-5 years of experience in clinical monitoring preferred;
• Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF and reconciling TMF documentation; and
• Excellent verbal and written communication skills in Portuguese and English.

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?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven-story building that is approximately 250,000 SQFT. In total, the headquarters' campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.

Perks (vary by location and position):

• On-site fitness center(s)
• Campus walking paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon

Awards:

• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets