Job Listing: Clinical Research Associate

Responsible for effectively managing and monitoring clinical trials for assigned projects, ensuring timely delivery of adequate and accurate clinical data, while maintaining an optimal relationship with external vendors such as CROs, suppliers, etc and internal team members.

-Serves as primary point of contract for assigned clinical studies
-Participates in project team meetings and provides clinical representation
-Develops or assists with the development of study design, protocol, case report form and other study specific documents essential to the appropriate implementation of clinical studies
-Coaches investigators to ensure optional compliance and performance, regulatory requirements, discrepancy reporting or ethical practice issues
-Ensures ICH, GCP and Operating procedures are followed in all study aspects
-Ensures accurate study product accountability
-Provides guidance to CROs for project implementation
-Ensures clinical data integrity by performing investigator/site training and source documentation
-Ensures timely subject recruitment and smooth implementation of studies by leading, guiding and motivating sites to complete study goals
-Ensures timely, accurate collection of Adverse Event, UADE and/or complaint reports and follow-up
-Presents information and data at investigator meetings as needed.
-Assists with the identification and recruitment of potential Investigators
-Assists with preparation of Ethics Committee submissions and notifications/submissions to regulatory authorities
-Obtains and reviews all Essential Study Documents necessary for study initiation
-Drafts or assists with drafting site and study budgets, participates in site negotiation and initiates site payments
-Conducts site visits as required – pre-study, initiation, interim, and close-out visits including site visit reports.

QUALIFICATIONS:
MINIMUM EDUCATION:
Bachelors degree or equivalent experience

MINIMUM SKILLS AND EXPERIENCE:
- At least 5 years of experience in clinical research and development and 2 years experience in clinical trial management
- Solid understanding of ICH and GCP
- Broad knowledge and cross functional understanding of clinical trial methodology and logistics
- Excellent communication and interpersonal skills
- Team player with ability to work independently
- Effective time management and organizational skills
- Consistent and follows through on commitments
- Ability to prioritize work in order to meet demanding/shifting timelines
- Excellent computer skills and knowledgeable of MS Word, PowerPoint, and Project

PREFERRED EDUCATION:
BS in a health-related science

PREFERRED SKILLS AND EXPERIENCE:
Medical device experience, CRA certification

TRAVEL REQUIREMENTS:
Ability to travel up to 25%

Required Skills for 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.