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Clinical Trials Assistant I

Occupational Summary
Perform a variety of research, data base and clerical duties of a routine and technical nature in support of multi-center clinical trials to ensure adherence to protocols and quality of information received.
 
Work Performed

  • Perform a variety of research, data base and clerical duties of a routine and technical nature in support of multi-center clinical trials to assist investigators in organizing, gathering and compiling clinical research data.
  • Maintain and update site demographics on computer data base; log forms received and file as appropriate; prepare reports from data base to include weekly reports and other reports as requested.
  • Receive and disseminate study-related regulatory documents and correspondence from assigned sites; assist in screening documents for completeness and compliance with protocol and appropriate regulations; assist in investigating incomplete, inaccurate or missing documents to ensure accuracy and completeness of data.
  • Assist in maintaining communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines; ensure that study materials and drug kits are shipped and resupplied as requested; respond to routine questions related to study protocol and refer more complex questions to others as appropriate; document all conversations in the data base.
  • Communicate regularly with regional data monitors as needed to provide information before and after visits to participating sites; review the monitor's post visit reports and follow up on problems identified as appropriate.
  • Communicate and coordinate with other study personnel as required to include data entry and randomization personnel, pharmacy, laboratories, study sponsors and others as needed for study implementation and routine problem resolution.
  • Attend routine weekly meetings and other meetings related to the clinical trial; stay abreast of information and any changes to study protocol.
  • Perform other related duties incidental to the work described herein.

Required Qualifications at this Level
 
Education/Training:
   

Work requires 1-2 years directly related experience in clinical trials; or 1 year of general research experience. Perform research, data base and/or clerical duties in support of clinical trials. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.

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