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Sr. Clinical Research Assoc./Study Manager-Pharmaceutical Job
Date: Oct 31, 2009
Location: Rochester, NY, 14673, USA
Job Title:
Sr. Clinical Research Assoc./Study Manager-Pharmaceutical
Req #:
5354BR
Job Description:
Job Duties:
- Assumes project management responsibilities for assigned clinical studies; participates in project planning, budget negotiations and expense analysis - Conduct and manage high profile clinical studies/trials which includes working closely with internal study team members/clinical scientists - Although this is an in-house position, you will still interact with investigative site personnel - Oversee execution of protocol - Contributes to the clinical protocol study design, development of Case Report Forms (CRFs), quality assurance, data management and reporting activities - Has involvement with Clinical Research, Clinical Operations and Project Mgmt of drug development activities - Identifies and evaluates issues related to the project and implements resolutions - Assumes in-house monitoring, assigns field monitors to projects as needed and required by GCP; performs on-site monitoring as needed by GCP - Participates in Investigator selection, recruitment and training and provides final recommendations - Plans and creates presentations of clinical research study information - Provides input on departmental decisions related to process and procedures - Minimal to no overnight travel (company uses CROs to perform field monitoring)
Qualifications
-
Education:
BA/BS(scientific field preferred). CRA certification a plus - 2 years of experience managing clinical trials, clinical trials resources and utilizing project management skills - 4 years of experience as a pharmaceutical study monitor with both in-house and field monitoring background preferred - Knowledge and understanding of current regulations related to Phase I - IV clinical research - Strong working knowledge of FDA, ICH and GCP guidelines. Knowledge of project management tools and practices - Ability to understand and review detailed clinical reports - Excellent communication and organizational skills. - Specialized Training: Courses in Clinical Research Monitoring and Clinical Project Management; Comprehensive knowledge of Microsoft Word, Excel and PowerPoint.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes
Status Full-Time
Sr. Clinical Research Assoc./Study Manager-Pharmaceutical
Req #:
5354BR
Job Description:
Job Duties:
- Assumes project management responsibilities for assigned clinical studies; participates in project planning, budget negotiations and expense analysis - Conduct and manage high profile clinical studies/trials which includes working closely with internal study team members/clinical scientists - Although this is an in-house position, you will still interact with investigative site personnel - Oversee execution of protocol - Contributes to the clinical protocol study design, development of Case Report Forms (CRFs), quality assurance, data management and reporting activities - Has involvement with Clinical Research, Clinical Operations and Project Mgmt of drug development activities - Identifies and evaluates issues related to the project and implements resolutions - Assumes in-house monitoring, assigns field monitors to projects as needed and required by GCP; performs on-site monitoring as needed by GCP - Participates in Investigator selection, recruitment and training and provides final recommendations - Plans and creates presentations of clinical research study information - Provides input on departmental decisions related to process and procedures - Minimal to no overnight travel (company uses CROs to perform field monitoring)
Qualifications
-
Education:
BA/BS(scientific field preferred). CRA certification a plus - 2 years of experience managing clinical trials, clinical trials resources and utilizing project management skills - 4 years of experience as a pharmaceutical study monitor with both in-house and field monitoring background preferred - Knowledge and understanding of current regulations related to Phase I - IV clinical research - Strong working knowledge of FDA, ICH and GCP guidelines. Knowledge of project management tools and practices - Ability to understand and review detailed clinical reports - Excellent communication and organizational skills. - Specialized Training: Courses in Clinical Research Monitoring and Clinical Project Management; Comprehensive knowledge of Microsoft Word, Excel and PowerPoint.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes
Status Full-Time
Nearest Major Market: Rochester
Job Segments: Clinic, Clinical Research, Healthcare, Management, Manager, Pharmaceutical, Research
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