Opportunity to work as a lead CRA supporting a niche hepatology portfolio! This position will support the branded operating company of a top 5 generic drug manufacturer. The role will offer high visibility in a dynamic environment responsible for two ongoing studies. The ideal candidate will be within the midwest/central regions based on required travel of this position.

Must Haves:

+ Bachelor's Degree in Life Sciences

+ 3-5 years of experience as a lead CRA

+ Mountain Time Zone

Description:

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.

+ CRA oversight- tracking metrics of 5-7 CRAs

+ Vendor Oversight

+ Responsible for 2 sites independently as well as oversight

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

WHY ACTALENT

+ Work with a dedicated career partner specialized in your scientific skill set

+ We advocate on your behalf so you get what you want and need out of your job

+ Get performance feedback, career advice, and access to ongoing professional development tools

+ Build your career and learn new skills through projects as diverse as your curiosity

+ You are eligible for benefits, sick-time, and competitive wages that are paid weekly

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 [email protected] (%[email protected]) for other accommodation options.