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Clinical Trials Coordinator 1


OCCUPATIONAL SUMMARY: Perform a variety of research, data base and clerical duties of a complex and technical nature in support of multi-center clinical trials, observational research, and research network support to support research and informational gathering activities.
 
WORK PERFORMED

  • Perform a variety of research, data base and clerical duties of a complex and technical nature in support of multi-center clinical trials and observational research to assist investigators in organizing, gathering and compiling clinical research data.
  • Coordinate and participate in a variety of duties involved in collecting, interpreting, documenting and summarizing descriptive, analytical and evaluative data in support of research and/or information gathering activities.
  • Coordinate the preparation of reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions.
  • Recommend new methods for collection and documentation of data; write and revise procedural manuals as required.
  • Assist in training of new personnel.
  • Maintain and update site and network demographics and performance metrics on computer database; log files received and file as appropriate; prepare reports from data base to include weekly reports and other reports as requested.
  • Gather documentation required for IRB and Data Use Agreements (DUA), submit applications, and track submissions.
  • Maintain ongoing communications with collaborators to provide information, track documentation and overall progress of clinical trials and observational research and adherence to established guidelines; respond to questions related to study protocol independently or refer to others as appropriate; document all conversations in the data base.
  • Assist Clinical Trials Coordinators and Project Leaders in general administrative activities as requested to include, but not limited to, providing input on adverse trends or problems noted and/or input regarding study modifications, development of Standard Operating Proce`res for clinical trials and observational research and revision of data collection forms and worksheets; discuss unusual requests or indications that a site is not in compliance with established guidelines.
  • Communicate and coordinate with other study personnel as required to include faculty, sponsors, network collaborators, data partners, and others as needed for study implementation and problem resolution.
  • Schedule and facilitate meetings; document minutes and action items.
  • 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 knowledge of basic mathematical, data collection and research principles normally acquired through an AA/AS degree
 
Experience: Work requires two years directly related experience in clinical trials research; or three years of general research experience. Perform a variety of research, data base and clerical duties in support of multi-center clinical trials. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
 
Preferred Skills: Excel, Word and Calendaring tool such as Outlook are expected.  Access experience is a plus. Strong communication skills, both written and verbal. Strong organizational skills.
 

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