Bilingual Clinical Research Associate (CRA) – Clinical Research Coordinator Experience

Résumé du poste

The Clinical Research Associate conducts pre-study, initiation, monitoring, and closeout visits for research sites while maintaining site correspondence and study-related databases. They are responsible for overseeing clinical research sites and reviewing patient charts and clinical research data to ensure compliance with SOPs and GCP.

Détails du poste

Medpace is growing quickly and we are seeking a Clinical Research Associate to join our team in Canada. We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work. This is a home-based position in Canada. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence and receive customized, expedited training, and efficient onboarding to familiarize experienced CRCs with Medpace systems. WE OFFER THE FOLLOWING Competitive bonus plans including Resourcing Bonus (following training completion and successful assignment to studies) and Yearly Travel Incentives Voluntary retirement scheme Home office furniture allowance, mobile phone and hotspot for internet access anywhere In-house travel agents, reimbursement for airline club and TSA pre-check Customized PACE training program based on your experience and therapeutic background and interest User friendly CTMS with electronic submission and approval of monitoring visit reports Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts Study assignments in various therapeutic areas with nation-wide site assignments National assignments with average of 2 protocols In-house administrative support for all levels of CRAs Opportunities to work with international team of CRAs Low turnover rates for CRAs No metric for minimum required days on site per month Flexible work hours across days within a week Opportunity for CRA leadership positions – Lead CRA, CRA Trainer, and CRA Mentor Annual team building events and socials with local Medpace employees Many additional perks unmatched by other CROs! Responsibilities Conduct pre-study, initiation, monitoring, and closeout visits for research sites according to Medpace/Sponsor SOPs and GCP; Maintain ongoing site correspondence and site files; Complete visit reports and maintaining study-related databases; Oversight and interaction with clinical research sites; and Review of patient charts and clinical research data. Qualifications Bachelor’s degree in life science related field from an accredited university; At least 2 years as a Clinical Research Coordinator; Bilingual in English and French; Thorough knowledge of the methodology related to the conduct and monitoring of clinical trials per ICH E-6 guidelines and per Part-C, Division 5 of the Health Canada Food and Drug regulations; Excellent interpersonal, written and verbal communication skills in English and French; Strong attention to detail and organization skills; Highly motivated, independent, flexible; Ability to travel between 60-70%; Ability to prioritize workload to meet timelines across multiple studies; and Proficient in Microsoft Office. 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.

Ce que vous ferez

The Clinical Research Associate conducts pre-study, initiation, monitoring, and closeout visits for research sites while maintaining site correspondence and study-related databases. They are responsible for overseeing clinical research sites and reviewing patient charts and clinical research data to ensure compliance with SOPs and GCP.

Exigences

Candidates must hold a bachelor's degree in science and possess at least 2 years of experience as a Clinical Research Associate or Coordinator. Proficiency in English and French is required, along with thorough knowledge of ICH E-6 guidelines and Health Canada Food and Drug regulations.

Avantages

• Competitive bonus plans • Resourcing bonus • Yearly travel incentives • Voluntary retirement scheme • Home office furniture allowance • Mobile phone • Hotspot for internet access • In-house travel agents • Reimbursement for airline club and TSA pre-check • Comprehensive health and wellness benefits • Paid time off

Compétences indiquées

• Gestion du temps · Souhaitée
• Organization skills · Souhaitée
• Regulatory Compliance · Souhaitée
• Souci du détail · Souhaitée
• Microsoft Office · Souhaitée
• Communication Skills · Souhaitée
• Google Cloud · Souhaitée
• data management · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical research
• Monitoring visits
• GCP
• ICH E-6 guidelines
• Site correspondence
• Data management
• Bilingual
• Communication skills
• Attention to detail
• Organization skills
• Microsoft Office
• Clinical trial methodology
• Regulatory compliance
• Time management
• Influencing Skills
• Cross-Functional Collaboration
• Administrative Support
• Continuous Development
• Furniture Cleaning
• Influencing Without Authority
• Organizational Skills
• Bilingual (French/English)
• Medical Devices
• Self-Motivation
• Research
• Multilingualism
• Biotechnology
• Cardiology
• Medical Records
• Metabolism
• Decision Making
• Pre-Clinical Development
• Clinical Research
• Clinical Research Coordination
• Clinical Trials
• Clinical Trial Management Systems
• Communication
• Training And Development
• Creative Thinking
• Electronic Submission
• Endocrinology
• Leadership
• Innovation
• Oncology
• Neurology
• Employee Onboarding
• Pharmaceuticals
• Verbal Communication Skills
• Resourcing
• Prioritization

Domaines d’emploi

• Healthcare
• Science & Research
• Administrative
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers