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Clinical Research Associate (CRA), Sr
11/13/2009 5:34:12 PM
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs — and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.
Prepares, collects, and tracks master study level documents and site non-regulatory documents, administers key clinical systems, produces reports on key clinical metrics, and supports clinical operations. Performs the activities associated with the evaluation, initiation, monitoring and collection of data, and closeout of clinical pharmacology trial sites. Ensures adequate protection of the rights of human subjects and the safety of all subjects, and ensures the quality and integrity of the data collected in Allergan-sponsored clinical trials.
Aligns execution activities with agreed upon project priorities, timings and quality specifications. The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
The percentage of time spent across roles for which the employee is responsible for will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
• B.A./B.S. (Life Sciences) or related field, or, R.N., M.S. or other advanced degree preferred
• Two years clinical study site monitoring experience
• Three years work experience in life science or medically related field including one year clinical research experience (eg, study coordinator)
• Previous experience as a CRA in the biopharmaceutical industry preferred
• Minimum of one year experience in Clinical Pharmacology
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Good understanding of clinical study budgeting and the drug development process
• Knowledge of concepts of clinical research and drug development
• General therapeutic area education and training
• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
• Self-starter with ability to work independently in a regional area with remote or minimal supervision
• Ability to work effectively in a team/matrix environment
• Ability to influence others without direct reporting relationships
• Ability to understand technical, scientific and medical information
• Demonstrated strengths in the following areas:
o Planning, organizational, project management and analytical skills
o Oral and written communication
o Time management
o Conflict management and resolution
o Problem solving
o Attention to detail
o Interpersonal and networking skills
o Relationship building
o Motivational skills
o Cross-cultural sensitivity
o Clinical study budgets
o Customer Service Orientation
• Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture)
• Ability to travel approximately 25%
For consideration please apply online using the following link: http://allergan.taleo.net/careersection/usa_external/jobdetail.ftl?lang=en&job=090739&src=JB-10081