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IntellecTechs

Founded by Veterans in Hampton Roads

Company Name:
Myriad Genetics, Inc
Approximate Salary:
19.23 - 21.00 Per Hour
Location:
Mason, Ohio
Country:
United States
Industry:
Biotech
Position type:
Full Time
Experience level:
Entry Level
Education level:
Bachelor's Degree

Clinical Development Assistant

 

As the Clinical Development Assistant you will be responsible for providing administrative and data entry support to the Assurex Clinical Development department located in Mason, Ohio. You will help ensure that the clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements. This full-time position will report to the Sr. Manager, Clinical Development.

 

  • Support the Clinical Development Associates with ensuring that the clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
  • Assist the clinical development team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and SOPs.
  • Assist with periodic review of study files for accuracy and completeness.
  • Assist Clinical Development Associates with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Assist in the establishment and maintenance of all partnership account documentation including all files, records and reports according to the scope of work and SOPS
  • Assist with the coordination and tracking of all information, communications, documents, materials and supplies for assigned projects
  • Perform source document verification and CRFs review
  • Review, escalate and manage quality issues
  • Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly
  • Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with account specific information

  • BS/BA with some experience in chart reviews preferred
  • Knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP and quality performance initiatives and processes
  • Excellent attention to detail and accuracy in work
  • Excellent organizational skills
  • Strong computer skills including Microsoft Office
  • Knowledge of CNS therapeutic area as well as CRO and/or diagnostic industry operations an asset
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Ability to manage multiple tasks in a fast-paced environment
  • Ability to work effectively under tight timelines and schedules
  • Ability to work independently and as a contributing team member
  • Must be flexible, innovative, and self-motivated

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.

 

Apply Here: http://www.Click2apply.net/37kqw3pq96wc9rcb

 

PI97880414

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