END DATE October 12, 2016

Senior Clinical Research Associate (Sr. CRA)

Therapeutics, Inc. - Jacksonville, FL

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  • Company
    Therapeutics, Inc. Therapeutics, Inc.
  • Location
    Jacksonville, FL
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Company Ref #
  • AJE Ref #

Job Description

** We are looking for a Senior CRA who would be home based in any major metropolitan area close to an airport hub (preferably Northern Florida region). Our home office is located in San Diego, Ca.

The Senior Clinical Research Associate must manage clinical study sites to ensure subject safety and compliance with the study protocol, timeline and budget, in support of on time and within budget regulatory submissions.
Routine responsibilities will include:

Assessment of the suitability of clinical sites to conduct specific studies

Initiation of selected clinical study sites by providing training related to the protocol and management of the study

Performance of routine monitoring of clinical study sites to ensure subject safety and protocol compliance

Verification of data entered on the CRFs is consistent with clinical notes and other source documents

Collection of completed CRFs and queries from clinical sites

Writing of monitoring visit reports

Ensure the accountability of all test articles

Close-out of clinical sites on completion of the study

Assist with study file audits and site audit preparation

Develop and maintain routine contact with clinical study investigators and staff

Assist with protocol, case report form and source document template development

Ensure compliance with appropriate regulatory (GCP, FDA, ICH, HBP, etc.) and internal guidelines

Assist with final report preparation

Assist with internal SOP/guideline development

Coordinate supplies forecasting and distribution

Communicate across departments and conduct project team meetings concerning status of the study and specific sites.

Mentor and training Clinical Research Associates on monitoring procedures and TI SOPs.

Must be willing to travel 60-80%