Ockham is a global provider of resources to the Biotechnology and Pharmaceutical Industry. We work with companies involved with clinical trials and other market approval processes to help them deliver their products on time and on budget. One of our clients in Waukegan, IL is looking for a In house CRA. This is a contract position.
Member of the clinical team. Responsible for assisting senior staff in planning study conduct.
Analyze and troubleshoot Clinical Trial Management System (IMPACT) data quality and perform compliance Analysis
Seeks input from IMPACT users to identify gaps where additional processes/support is required.
Propose process improvements
Coordinate study set up across multiple systems (EDC/IRT,etc)
Effectively interact with Clinical personnel and develop cross-functional contacts
Drive compliance of system usage by Clinical personnel through reports and checking study information in the system
Define/analyze quality metrics
Inform/Train system users on how to maximize the available tools.
BA, BS preferred
Experience: 3-6 years experience in the Pharma industry or clinical study coordination
Understanding/experience with Clinical Trial Management Systems, Electronic Data Capture/IVR systems
Demonstrated analytical and critical thinking skills.
Possesses presentation and communication skills, with the ability to communicate effectively
Must be proficient in computer skills, learn new software/technology quickly.
Must have a good understanding of the overall Global Clinical Study process
Must have good organizational skills and be detail-oriented
Must possess the ability to work in a team environment
Keywords: SAS, SAS Programmer, Statistics, Statistical Programmer, Statistical Analysis, ISS/ISE, Biostatistician, Biostatistical Programmer, Clinical Trials, Clinical Research, Clinical Studies, Pharmaceuticals, Drug Development, IND, NDA, Data Management, Data Manager, Clinical Data Manager, Clinical Data Coordinator, Drug Safety, Drug Safety Specialist, Drug Safety Associate, Pharmacovigilence, Drug Safety Nurse, Drug Safety Physician, Medical Writer, Medical Writing, Regulatory Affairs, Regulatory Submissions, Clinical Project Manager, Clinical Trials Specialist, Medical Services Specialist, BSN, RN, Clinical Research Associate, CRA, Clinical Study Manager, Clinical Study Monitor, Clinical Trials Monitoring, Regional CRA, Regional Clinical Research Associate, In-house CRA, In-house Clinical Research Associate, CDISC, SDTM, ADaM, Rave, Medidata, InForm, Home based, telecommuting, ASG, Ockham
Ockham Development Group Inc - 15 months ago
Ockham Development Group, Inc., is a privately held corporation with 35+ employees headquartered in Cary, North Carolina, near the universit...