Clinical Research Associate (Home-Based) - Clinical Research Coordinator Experience

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.

Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!

This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our PACE Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.

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.

CRA PERKS

• Competitive travel bonus
• Flexible work hours across days within a week
• In-house travel agents
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts
• Opportunities to work with international team of CRAs

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify 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;
• On-site and virtual / remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations / deficiencies and corrective / preventive actions to bring a site back into compliance and mitigate risks moving forward;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and / or 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;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• 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

• Must have a minimum of a Bachelor’s degree in a health or science related field;
• Experience as a Clinical Research Coordinator (minimum 1 year);
• Ability to travel 60-70% to locations in the DACH region is required; some visits may be conducted remotely;
• Proficient knowledge of Microsoft Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management
• Excellent verbal and written communication skills in German and English.

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