Lead Clinical research Associate (RE-12453150) Palo Alto, California

Salary: USD90 - USD120 per hour

 

Reports to:

Direct report to SVP of Clinical Development & Operations and Work Closely with the Sr. Director of Clinical Operations and Data Management

Qualifications & Experience:

Degree in Bio-Medical, Nursing, Science, or related field (or equivalent); minimum BS or equivalent.

Minimum of ten (10) years of clinical research experience in pharmaceutical, biotech, medical device, and other life science industries. Specific emphasis on site monitoring and management as well as project coordination;

Strong GCP knowledge and experience in Clinical Trial Management;

Minimum of three (3) years of Mid-level management experience;

Working proficiency in Microsoft Office (Word, Excel and Power Point);

Professional use of the English language; both written and oral.

Position Overview & Purpose

The Senior Clinical Research Associate (Sr. CRA) is responsible for study-specific activities. Duties include the appropriate oversight of CRO site monitoring capabilities, co-monitoring and resolution of site issues, maintenance of the Trial Master File (TMF) and site documentation. In addition, this position encompasses liaison duties to investigator sites, clinical vendors, and internal staff. The Sr. CRA applies working knowledge and expertise, as well as high-level management experience in clinical research monitoring to ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP including SOPs, and with applicable regulatory requirements.

Term & Scope of Position

2 year Contract

Essential Job Functions

 

Ÿ Perform Co-Monitoring visits for Interim and Close-out visits with the CRO monitors to ensure compliance with the protocol, study plans, and regulatory requirements;

Ÿ Conduct Training to CRO Monitors and Investigator Sites as appropriate to assist in improving study conduct and project work-flow;

Ÿ Provide direction and guidance to Monitoring CRO and The company team members working on project;

Ÿ Perform quality compliance oversight of CRO monitoring work, including review of Monitoring Visit Reports and