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Oncology Monitor: MedFocus

Job ID0000069057
Company NameMedFocus
Job CategoryPharmaceutical/Biotech; Other
LocationHouston, TX
Position TypeFull-Time, Contract
Experience5-10 Years Experience
Desired Education LevelBachelor of Science
Date PostedOctober 23, 2009
View MedFocus profile and job listings

ONCOLOGY MONITOR

COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

Our client is dedicated to making a major positive impact on the lives of people with serious diseases and is seeking to add an Oncology Monitor to their team in Texas (Houston) or Arizona.

RESPONSIBILITIES:
• TA: Leukemia/Oncology
• This position is responsible for ensuring clinical site activities are conducted in compliance with FDA regulations, GCP/ICH guidelines, company SOPs, and site SOPs. This role requires strong knowledge of clinical study activities, excellent communication skills, ability to work in a team unit, and relationship building with site research personnel.
• Build strong, long-term relationships with the investigators and study coordinators based on respect, knowledge, and commitment to appropriate clinical research practices.
• Perform site initiation, interim monitoring, co monitoring, close out visits, CRF and study documentation review and tracking
• Assure completion of project tasks within defined timelines. Conduct monitoring and other study activities in accordance with company SOPs, GCP/ICH guidelines, FDA regulations and project requirements.
• Identification & implementation of site training or corrective action as necessary.
• Assist sites in development and implementation of patient recruitment strategies for studies.
• Identify training needs and provide training for clinical site team.
• In-depth knowledge of FDA regulations and GCP/ICH guidelines.

QUALIFICATIONS:
• BS degree w/ min 5 yrs experience (5 yrs required)
• Travel 4 days per week, roughly 80%
• Therapeutic experience with Oncology. (Leukemia) a plus
• In-patient Monitoring experience required
• EDC and iVRS experience (required)
• Fully functional home office

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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