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Clinical Research Coordinator
Woodland International Research Group
- Clinical Operations
Responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and Site Director. Maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
Essential Job Functions
Knowledge, Education and Experience
- High School Diploma or its equivalent; College degree preferred
- Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
- Able to communicate with providers, co-workers, sponsors, and others in collaborative and courteous manner.
- Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.
- Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
- Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Skills and Abilities
- Excellent communication skills (interpersonal, written, verbal)
- Ability to perform overnight business travel
- Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
Working Conditions and Other Information
Equipment and Materials Used
- Standard office equipment including computer, copier, fax, telephone, etc.
- Sitting and viewing computer screen for long periods of time
- Extensive repetitive hand/wrist movements (telephone console and computer keyboard)
- Lifting (up to 30 lbs.)
Environmental Demands and Potential Hazards
- Exposure to hazards from fluorescent lighting, video screens, computers, copiers, faxes, etc.
- High levels of stress for long periods of time
- Environment will range from business office setting to clinical areas such as inpatient unit and clinical screening areas. The position requires contact with biological samples, individuals with potentially infectious diseases and with toxic, harmful, or potentially hazardous compounds, solutions, and medications. Noise level can range from quiet to moderate volume.
- The position also requires scheduled on-call availability of varying degrees based on demands of specific studies, staff availability, and coordination of schedules.
Job Type: Full-time
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