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Clinical Research Associate

Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
8/4/2014
Position Type:
Full time
Job Code:
CRA
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Research,

Job Description

** We are looking for a CRA who would be home based in any major metropolitan area close to an airport hub (preferably Texas, the Southeast or Midwest).

MAJOR RESPONSIBILITIES AND DUTIES:
The 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%

Requirements

QUALIFICATIONS:
The ideal candidate will have a Bachelor’s degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent and at least 3 years experience in clinical research or the medical field or a combination of education and experience that indicates the ability to perform the tasks associated with the Clinical Research Associate position. This candidate must possess a knowledge/understanding of the principles of clinical research and drug development. Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.

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