In House CRA

This is an excellent opportunity for a seasoned clinical research professional to apply established skills with both marketed and developmental products through managing new clinical studies.
The incumbent will initiate and coordinate study start-up activities to include protocol and investigator brochure writing and review, investigator selection, investigator meetings, budget planning and review, contract preparation, vendor selection, site selection, and CRF design and review.
Manage study activities that may include CRO, Central Lab, and other vendors, report on status, and ensure timely completion within budget.
Monitor, co-monitor, and train vendors and clinical sites to ensure adherence to the protocol and compliance with ICH/GCP Guidelines.
Support collection and review of essential document handling to include trip report approval.
Significant interface with Global Project Team members including Outsourcing, Clinical Supplies, Quality Assurance, Statistics, Data Management, Safety, Medical, Operations, Pharmacology, Regulatory, and Marketing.
Assist in preparation of clinical study reports for regulatory submissions and scientific publications.

ASG, Inc. is a nationwide contract consulting and contingency recruiting firm. Our reputation for excellent service, our knowledge of the market place, and our success in the recruiting industry make it possible for us to provide complete and comprehensive contract consulting and contingency technical services. Align yourself with ASG and get: challenging assignments and competitive compensation (with or without benefits). Our job is to keep you focused on your work and to provide you with a comfortable working relationship with us, your business partner, ASG.
REQUIREMENTS
The qualified candidate will have a minimum of three years experience as a CRA prior to hire date that includes site management and preferably significant experience with monitoring clinical studies.
Experience with vendor (CRO, Central Lab, etc.) management also preferred.
The candidate must have strong knowledge and demonstrated practice of ICH/GCP Guidelines.
The candidate should have good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure in a highly matrixed environment.
Familiarity with cardiovascular, metabolic, or preventative medicine is beneficial. Experience with regulatory submissions is a plus.
Bachelors Degree (BA/BS), from an accredited college or university, preferably in a health or biological science field is required.
A Masters Degree and/or RN and/or CRA certification is preferred.

If you would like to be considered for this position, please forward your resume to [Click here for email] please reference the job title and number.