Lead Clinical Research Associate

JOB DESCRIPTION

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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.

With a network of almost 30, consultants and more than 4, clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune .

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through :

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.