Clinical Research Associate jobs in Dallas, TX

Working with a small US based pharmaceutical company looking for an experienced Lead CRA! The ideal candidate will have existing experience serving as a lead and comfortable with regular travel. NASH experience is desired.

Description:

• CRA oversight- tracking metrics of 5-7 CRAs
• Vendor Oversight
• Responsible for 2 sites independently as well as oversight of additional

Location: Mountain time

The candidate will be primarily responsible for assisting the Clinical Operations team in the execution of clinical trial deliverables in an effective and efficient manner. The candidate will be responsible oversight of investigational sites in the United States. This includes: overall site management, and monitoring (including start-up, initiation, routine monitoring, and close-out visits), monitoring inventory of ancillary supplies, file maintenance, and ensuring recruitment goals are met.

Requirements/Qualifications:

- At least 3 years as a full-time Lead regional monitor working for a sponsor or Contract Research Organization (CRO)

- Experience managing aspects of CRO functions is a plus

- Travel is required for the position, this may be extensive at times

- Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion

- Extensive experience collaborating/interacting with counterparts at sponsor and other CROs/vendors (laboratories, drug depots, etc.)

- Experience managing clinical trial investigational sites

- Conducting site feasibility assessments, participating in or managing the site selection process, analyzing patient recruitment and retention rates

- Organize and perform site initiation visits and site training activities

- Perform periodic monitoring visits

- Verify biological sample collection, storage, and shipping procedures at the site

- Verify laboratory data is reviewed by the investigator, properly captured in the case report form, and if necessary, is being reconciled properly within the CRF

- Organizing and monitoring investigator study files

- Preparing and organizing local institutional review board(IRB)/ethics committee (EC) submissions in collaboration with the site(s) and Clinical Trials Associates

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