高级临床研究助理(CRA)- 圣保罗远程办公
Senior Clinical Research Associate (CRA) - Remote in Sao Paulo
职位名称:高级临床研究助理(CRA)- 圣保罗远程办公
工作地点:圣保罗,不可用,巴西
工作地点类型:远程办公
工作合同类型:全职
职位级别:
我们在拉丁美洲的业务正在扩展,Medpace 正在寻找有经验的 CRA 加入我们在巴西不断壮大的团队!在 Medpace 的临床研究助理职位提供了在药物和医疗器械研发领域开展令人兴奋的职业生涯的独特机会。对于那些对医学和/或健康/生命科学领域有兴趣和背景的人士,想要探索研究领域、在巴西各地旅行,并成为将药品和医疗器械推向市场团队的一员——这可能是适合你的机会!
我们成功的临床研究助理来自医疗和其他相关科学领域的多样化背景。
PACE – MEDPACE CRA 培训计划
Medpace 提供全面的初始和持续培训,这是其他 CRO 无法比拟的。通过我们的 PACE 培训计划,你将与其他追求 CRA 优秀表现的专业人士一起:
- PACE 提供一个平台,使你能够有效地、自信地履行职责,提升现有能力,并最终成为高效独立的 Medpace CRA。
- PACE 将通过互动讨论和实际工作的练习与实习来培养你的 CRA 技能。
- 除了内部和现场培训,你还可以参与其他临床研究部门的核心轮岗,学习药物/设备开发和审批过程的其他方面。
意外的回报
这个职位将使你通过提升药品和医疗器械来产生广泛的影响。CRA 职位还提供许多其他独特的优势,包括:
- 动态的工作环境,每天有不同的职责;
- 多个治疗领域的丰富经验;
- 在治疗和监管专家团队中工作;
- 明确的 CRA 晋升和发展路径,有机会进行指导和管理晋升;
- 有竞争力的薪资和显著的出差奖金机会。
职责
- 按照批准的方案对研究站点进行资格评估、启动、监查和结题访问;
- 与医疗站点工作人员沟通,包括协调员、临床研究医生及其站点工作人员;
- 确保充分的
查看英文原文
Job Title: Senior Clinical Research Associate (CRA) - Remote in Sao Paulo
Job Location: São Paulo, UNAVAILABLE, Brazil
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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;
- 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; and
- Excellent verbal and written communication skills in Portuguese and English
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 improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
· · Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
·
· Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
- Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
·
· Office based environment with on-site mentors
- Defined career paths with clear advancement opportunities
- Industry renowned onboarding and training programs designed to accelerate professional development
- Ongoing training and continuous learning opportunities throughout your career
- An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee 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.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
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Originally posted on Himalayas