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Senior Clinical Research Associate Job
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| Employer Name: Confidential |
SpiderID: 2225859 |
| Location: San Jose, California |
Date Posted: 5/16/2008 |
| Wage: $85K-$95K |
Category: Healthcare |
| Job Code: 2665 |
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Job Description:
Job Responsibilities:
1) Coordinate/execute clinical research activities for multiple or complex single studies
2) Handle day-to-day field operations, including overseeing CROs, contract CRAs and vendors with guidance from senior management
3) Manage assigned studies through all phases of study process, including budgets and timelines
4) Plan, forecast and manage study logistics and develop study operation documents and data collection forms
5) Identify, qualify, train and manage study sites, as well as conduct and document study per protocol, GCP/ICH guidelines and SOPS
6) Ensure that data quality and study-related documents adhere to protocol, government regulations and other relevant regulations along with GCP/ICH guidelines
7) Identify study site issues through documented site reports and other sources of information and bring them to the attention of the senior management
8) Evaluate and select new study investigators under the direction of the senior management
9) Maintain Project Tracking System (updated with current study status)
10) Provide accurate progress reports on assigned studies
11) Participate in cross-functional departmental meetings and interface with personnel directly or indirectly involved in the management of the clinical studies
Job Requirements:
1) Bachelor's/Master’s degree in Life Sciences
2) 5 – 8 years of CRA experience in the bio-technical and/or pharmaceutical industry
3) Experience in managing multiple projects simultaneously with aggressive timelines
4) Experience and demonstrated ability to work at a high level of productivity with minimum of infrastructure
5) Good understanding of statistics and protocol development for new products
6) Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement, good judgment, professionalism and independent interfacing with CROs, study coordinators and investigators
7) Ability to organize and manage CROs, consultants and multiple KOL sites participating in a clinical study
8) Ability to interpret and evaluate clinical data and literature
9) Ability to identify study-related, CRO- or site-related issues, determining the causes and possible solutions to the problem
10) Detail-oriented
11) Proficiency in MSWord, Excel and PowerPoint essential
12) Excellent written and verbal skills
13) Willingness to travel – up to 50% (as needed)
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02665.html
Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Company Profile:
Our client is a rapidly growing biopharmaceutical company headquartered in Long Beach that is focused on the development and commercialization of skin healthcare therapeutics. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate.
Contact Information:
| Contact Name: Jennifer Huston |
Company Type: Recruiter |
| Company: Sterling-Hoffman Life Sciences |
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| City: Toronto |
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| State: Ontario |
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| Zip: M5G 1T6 |
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Web Site: http://www.sterlinglifesciences.com/
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