Regional - Clinical Research Associate
Location: Plainsboro New Jersey
Description: Green Key Resources is at the momment seeking for Regional - Clinical Research Associate right now, this vacancy will be placed in New Jersey. Detailed specification about this vacancy opportunity kindly read the description below. Qualifications
- BA/BS degree in science/health care field or nursing/medical degree or equivalent combined education and experien! ce.
- Minimum 5 years of independent monitoring experience (all types of visits) in the US.
- Must have Breast cancer/Oncology experience and CRO experience.
- Experience with feasibility assessment is a plus.
- Demonstrates a high level of communication skills and provides clinical and technical support for Clinical Research Associates and administrative staff.
- Strong working knowledge of GCPs, ICH Guidelines and FDA Regulations.
- Ability to travel up to 70% of the time.
- Proficient use of standard MS Office applications (Word, Excel and PowerPoint).
- Ability to multitask and work efficiently in a fast-paced environment.
- Excellent command of English, written and spoken and professional communication via email and voicemail.
- Must have valid current driver's license.
- ACRP/CCRA or equivalent certification/credentials preferred.
- Project activitie! s and monitoring functions associated for Phase I-IV clinical ! research studies.
Comprehensive understanding and understanding of the drug development
process, Good Clinical Practices (GCP), and relevant regulations.
-
Performs management of study site activities to ensure the integrity of
clinical data in adherence to all applicable regulatory guidelines and
Standard Operating Procedures (SOPs) and Project Specific Operating
Procedures.
- Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits.
- Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.
Maintains regular review of site regulatory binder and ensures proper
storage, dispensation, and accountability of all investigational
products and trial related materials.
- Maintains timely and effective communication among team members and site staff.
- Routinely anticipates/iden! tifies potential issues and implements corrective actions independently.
- .
If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Green Key Resources.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Sat, 07 Sep 2013 13:14:16 GMT