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Clinical Research Associate

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JOB TITLE:   In-House Clinical Research Associate

REPORTS TO: Lead In-House Clinical Research Associate

JOB SUMMARY:

Provide administrative and limited clinical support for large oncology multi-study clinical research program.  The primary function of the In-House Clinical Research Associate is data entry completion of case report forms in conjunction with the management of the administrative aspects of the protocol.

RESPONSIBILITES:

  • Complete case report forms and resolve queries in a timely manner as detailed in protocol(s).
  • Coordinate the collection of data according to the research protocol and case report form guidelines.
  • Work closely with research nurse coordinator and clinic staff to resolve data discrepancies.
  • Document and report clinical study progress to external and internal study teams.
  • Update site research staff of any changes in documentation requirements.
  • Maintain calendar of study monitor schedule and provide data as requested by monitors and make timely corrections to research data as needed.
  • Participate in site initiation, interim monitoring and study close out visits and sponsor and FDA initiated audits as needed.
  • Maintain and audit clinical source data to ensure adherence to the research protocol.
  • Responsible for the shipment of CRF materials and laboratory samples as needed, also prepares research materials in accordance with protocol.
  • Manage all administrative aspects of Phase I, II, III and IV clinical trials.
  • Special projects and other tasks as assigned.
  • In collaboration with research nurse coordinator, educate research staff about data collection process.
  • Maintain accurate screening and enrollment logs.
  • Inform Principal Investigator of any monitoring or sponsor issues or concerns.
  • Work closely and effectively with all other department personnel.

QUALIFICATIONS:

KNOWLEDGE, SKILLS & ABILITIES – Position requires the following minimal requirements:

Clinical research certification (or in progress)

  • Knowledge of GCP and ICH regulations and guidelines
  • Knowledge of oncology terminology is a plus
  • Strong interpersonal and communication skills; excellent organizational skills
  • Capable of critical thinking and have the ability to work independently and make decisions
  • Detail oriented, have ability to multi-task, problem solve, and prioritize in a fast paced clinical environment
  • Computer proficient including Word, Excel, PowerPoint and Outlook; ability to learn new software

EDUCATION

  • Bachelor’s degree in science related field

EXPERIENCE

  • 2 years in clinical research

Non-Exempt Position:      salary based on experience