Clinical Research Associates Needed

Clinical Research Associates Needed

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We are doing a search for Clinical Research Associates (CRA’s) in central NJ. If you have the following requirements, live in NJ and wish to apply please send us your resume (in Word) and let us know in the subject line the position you are interested in. All resumes for this consultancy will be kept confidential and will not be forwarded without your permission.

Qualifications:

• Life Science/Nursing graduate or equivalent with at least 2 years of clinical monitoring/site management experience.
•  US drivers license.
•  Computer literacy (word processing and spread sheets).
•  Knowledge of ICH/GCP, relevant international and local regulations relating to clinical research.

General Job Description:

•  Proactively manage a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met.
•  Ensure studies are run in line with ICH/GCP, local laws and SOPs and procedures.
•  Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
• Inform the PI and site staff of all issues.
• Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.
•  Responsible for all aspects of site management from collaboration on site selection to study closeout.
•  Train site staff on the protocol, protocol amendments and processes.
• Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.

Data Quality

•  Ensure that data monitored meets target quality standards.
•  Ensure that data is entered into systems in a timely manner.

Reporting

• Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.
• Ensure all issues are correctly identified and catalogued.
• Proactively manage issues to appropriate closure.
•  Maintain accurate site-level information on corporate clinical trials registry.

Documentation

•  Obtain critical information to enable generation of IIP documentation.
•  Assist CTA in gathering IIP documentation where required to ensure timely site set up.
•  Maintain the SMF and SMF log.
• QC relevant documents in a timely manner.
•  Generate site-monitoring reports.
• Maintain all appropriate monitoring logs.