Experienced Clinical Research Associate

7 days ago

Navi Mumbai Maharashtra, India Medpace, Inc. Full time

Job Summary:
Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include:

- Nurses
- Dieticians
- Pharmacy Technicians
- Pharmaceutical/Device Sales Representatives
- Biotech Engineers
- Health and Wellness Coordinators
- Research Assistants.

**_ PACE_**_®_** - MEDPACE CRA TRAINING PROGRAM**

No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our _PACE_®_ _Training Program, you will join other **P**rofessionals **A**chieving **C**RA **E**xcellence:

- _ 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 takes you on a journey through travel and excitement which 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

**Home-based option available for CRA for more than 1 year of monitoring experience.**

Responsibilities:
As a CRA, you will specifically be responsible for the following:

- 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;
- 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;
- 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:

- Bachelor's degree with at least 2 to 4 years of experience as a Clinical Research Associate;
- Willing to travel approximately 60-80% nationally;
- Familiarity with Microsoft® Office; and
- Strong communication and presentation skills a plus.

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 headquarter's campus includes five buildings and approximately 600,000 SQFT. The company al

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