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Clinical Research Associate
3 meses atrás
Job Summary:
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
No clinical 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 inhouse and fieldbased 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.
- Dynamic working environment, with varying responsibilities dayto 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;
- 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 followup letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications:
- Bachelor's degree in a health or science related field;
- 25 years of experience in clinical monitoring;
- Experience in Oncology and desirable experience in infectious disease;
- 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
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.
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 buildin
