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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