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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.

  • 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.
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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