Job Listing: Senior Clinical Research Associate

Position Summary:

In-house Senior CRA will be responsible for the organization and conduct of clinical studies in compliance with Clinical Affairs policies, Regulatory Authority and ICH Guidelines.

Medical device experience is a plus.

Experience reviewing trip reports.

Managing budgets and timelines.

Vendor and CRO management experience.


Duties & Responsibilities:

-responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials.

-preparation of protocols including study design, case report forms, study procedures

-develop enrollment feasibility evaluations based on protocol synopsis

-draft informed consents based on study and regulatory requirements.

-prepare research agreements and negotiate study budgets with sites

-perform pre-study and study initiation visits

-monitor clinical studies for protocol and regulatory compliance including

-adverse event reporting

-manage the day-to-day oversight of the CRO personnel

-perform study closeout procedures

-prepare/coordinate final reports

-prepare annual safety reports


Qualifications & Education:

-comprehensive knowledge of FDA regulations and ICH Guidelines

-Bachelors Degree in Science or medical field preferred

-3-5 years previous pharmaceutical or device clinical trial experience

Required Skills for Senior Clinical Research Associate Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.