2001 NIH Postdoctoral Job Fair

PRA International

Company Description: PRA is a leading international drug development organization with more than 1,200 employees worldwide and anticipated 2001 revenues of approximately $125 million. Founded in 1976, the company has provided services on a contract basis to the pharmaceutical and biotechnology industries for more than 25 years. PRA is today the seventh-largest contract research organization (CRO) in the world.

PRA’s corporate headquarters are located in McLean, Virginia, just outside of Washington, DC. Clinical trials and related services are conducted from five Trials Management Centers located in Charlottesville, Virginia; Lenexa, Kansas; Mannheim, Germany; Reading, England; and Eatontown, New Jersey. The company also operates a 56-bed inpatient clinical research center in Lenexa, Kansas; an international data processing center in Swansea, Wales; and a satellite offices in San Francisco, California; Paris, France; and Wilmington, Delaware.

PRA’s mission is to be the best clinical development organization in the world. The company has invested heavily in senior medical and scientific staff, staff development programs, well-designed facilities, information technology, integrated information systems, process engineering, customer account management and quality assurance systems to help it achieve this goal. In the process, PRA has established a reputation for outstanding customer service, quality work products and reliable performance. PRA counts among its customers the top pharmaceutical and biotechnology companies in the world, including European, Japanese and American firms.

PRA offers a broad array of services that encompass the entire spectrum of clinical development programs, from filing of Investigational New Drug (IND) and similar regulatory applications to product registration and post-marketing surveillance on an international basis. Core services include:

• Drug development and regulatory strategy plans
• Phase I (first-time-in-man) clinical trials
• Phase II through IV multi-center (international) clinical trials
• Development and analysis of integrated global clinical databases
• Preparation and submission of regulatory filings in North America and Europe
• Long-term drug safety programs

PRA has a unique, decentralized organizational structure where each of its six Trials Management Centers are dedicated to a specific group of customers in order to provide the best possible customer service. A senior-level account management team is assigned to work with each of these customers to understand their organization, culture, objectives and needs and plan resources to meet critical research timelines. These account teams help the company ensure stable, long-term business relationships with its most significant customers.

Customers choose to work with PRA for a variety of reasons. Foremost among these are its outstanding customer service, full range of clinical development services, international coverage, therapeutic expertise, and strong data management capabilities. In the past year PRA has worked with all 10 of the top 10 multinational pharmaceutical companies, 7 of the top 10 biotech companies, and 7 of the top 10 Japanese companies. Over 70% of PRA's revenues are derived from repeat business from customers with which it has had long-standing business relationships. 

Position Descriptions: Project Manager

(Charlotesville, VA, Eatontown, NJ, Horsham, PA, and Lenexa, KS)

Qualified candidates must possess an undergraduate degree in a clinical or health related field from an accredited institution; advanced degree preferred. Minimum two - four years experience in clinical biomedical research required, oncology experience a plus. Must have a minimum of two years of progressive employment-related experience in project scheduling, managing resources, and coordinating team activities. Must be detail-oriented, computer proficient in a Windows environment, and possess superior interpersonal and organizational skills.

Director, Project Management

(Lenexa, KS)

Qualified candidates must possess an undergraduate degree in a clinical or health related field from an accredited institution; advanced degree preferred. Must have at least five+ years clinical research experience with a minimum of two years progressive, employment-related experience in project scheduling, managing resources and coordinating team activities. Demonstrated experience with clinical plan development, regulatory compliance and data management required. Must have established experience with the full clinical development process through regulatory submissions. Must be detail-oriented, computer proficient in a Windows environment, and possess superior interpersonal and organizational skills. 

Senior Biostatistician

(Eatontown, NJ, Lenexa, KS)

Qualified candidates must possess a PhD or DrPH in biostatistics/statistics from an accredited institution and greater than three years of pharmaceutical industry, biotech and/or contract research organization experience. Candidates with an MS in Biostatistics or Statistics and greater than five years of industry experience are also encouraged to apply. Play a leading role in the design, analysis, and reporting of clinical studies for our clients. Good communication skills and knowledge of SAS (and other statistical software) are required. Regulatory submission experience and previous interaction with the FDA is a plus. Must be detail-oriented, computer proficient in a Windows environment, and possess superior interpersonal and organizational skills.

Senior Clinical Research Associate

Regional(home based) and Lenexa, KS, Eatontown, NJ

Qualified candidates must possess an undergraduate degree in a clinical or health related field from an accredited institution; advanced degree preferred. Must possess three+ years experience in monitoring and managing clinical trials for a contract research organization, pharmaceutical or biotechnical company and have a thorough knowledge of Good Clinical Practice and FDA regulations. Some travel required. Must be detail-oriented, computer proficient in a Windows environment, and possess superior interpersonal and organizational skills.

Quality Assurance Auditor II

Eatontown, NJ

Qualified candidates must possess an undergraduate degree in a clinical or health related field from an accredited institution; advanced degree preferred. Minimum two years experience in clinical quality assurance auditing (Good Clinical Practice compliance) required. Conduct site, database and system audits. Must understand pharmaceutical clinical research including, case report form design, clinical trials management, and data management. Must be detail-oriented, computer proficient in a Windows environment, and possess superior interpersonal and organizational skills.

Clinical Data Coordinator II

Charlottesville, VA, Eatontown, NJ, Lenexa,KS, and Horsham, PA

Qualified candidates must possess an undergraduate degree in a clinical or health related field from an accredited institution; advanced degree preferred. Must have four years experience managing multiple projects and deadlines. Should have a strong clinical background with contract research organization or pharmaceutical experience preferred. Solid customer service focus required. Must be detail-oriented, computer/database proficient in a Windows environment, and possess superior interpersonal and organizational skills.

Supervisor, Clinical Trials Services

Charlottesville, VA, Eatontown, NJ, Horsham, PA, and Lenexa, KS

Qualified candidates must possess an undergraduate degree in a clinical or health related field from an accredited institution; advanced degree preferred. Minimum of five+ years experience in a clinical development environment, biopharmaceutical, or contract research organization industry is required. Must possess the demonstrated ability to plan, implement, and monitor multi-center clinical trails, including experience with investigator enrollment, site monitoring, case report form management, and computer-based clinical systems. Must possess a thorough knowledge of regulatory requirements and good clinical practices. Minimum of two+ years experience managing professional staff or comparable project management experience is required. Selected candidate will schedule and supervise the project activities of assigned staff, and provide leadership in the delivery of clinical trials services to clients. Must be detail-oriented, computer proficient in a Windows environment, and p!

ossess superior interpersonal and organizational skills.