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International Clinical Research Associate Job
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| Employer Name: HireFighters |
SpiderID: 2221726 |
| Location: San Diego, California |
Date Posted: 5/12/2008 |
| Wage: Open but flexible |
Category: Medical/Health |
| Job Code: ICRA |
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| Number Of Openings: 1 |
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Job Description:
Please forward resumes for immediate consideration to greg@hirefighters.com. I will call you shortly after receipt to tell you more about this opportunity.
Join a company that is developing ground-breaking products that are really helping people. Tremendous management team is aiming this company for an IPO very shortly. All new employees receive excellent salaries, options, World-Class benefits packages and due to the growth of the company there are many different career paths you can choose.
Intl Clinical Research Associate
Category: International Marketing
Responsible for the conduct of small-scale international clinical trials of spinal implants. Position involves the understanding of scientific clinical trials as well as managing close relationships with the surgeon investigators and their research staffs.
Essential duties and responsibilities include the following. Other duties may be assigned.
Work with surgeons and R&D staff to assist with the creation of clinical trial protocols.
Has primary responsibility for monitoring international clinical sites and forming close working relationships with those sites. It is expected that the total number of sites will be approximately
5-10.
Is responsible for coordinating all aspects of conducting international clinical studies: having protocols and case report forms professionally translated, verifying compliance with local rules regarding clinical research, managing third-party vendor relationships as they pertain to the conduct of international clinical trials, and performing regular monitoring visits.
Travel to Central and South America is expected to be routine. Some European travel will also be required.
Is expected to learn the basic functions of the surgical instruments and implants under study, and occasionally be present in the operating room to observe surgery.
Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be fluent in English and Spanish. Candidates unable to speak fluently in both languages will not be considered.
Fluency in Portugese and/or German is a plus, but not a requirement.
Must understand medical device trial monitoring as it is conducted for FDA IDE trials.
A basic understanding of statistics is preferred.
Must be capable of writing a clinical study protocol based on inputs and discussions with senior engineering staff and surgeons.
Education and/or Experience:
At minimum, a Bachelor's degree in a scientific field is required.
At least three years experience monitoring FDA-regulated medical device trials. Experience in orthopedics, particularly the spinal surgery field is preferred but not required.
Computer Skills:
Proficient with Microsoft Word, Excel, and Powerpoint. Must be capable of learning how to manage clinical trial data in a database format.
Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 2
Education Required: Bachelors
Overnight Travel: 25-50%
Vacation Time: 3 weeks / year
Job Benefits:
Health/Dental Benefits, Retirement Benefits, Stock or Stock Options, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Flex Time, Relocation Assistance, Tuition Reimbursement, Casual Dress, Regular Employee Outings, Other Benefits
Contact Information:
| Contact Name: Greg Berig |
Company Type: Recruiter |
| Company: Hirefighters |
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| City: Cedar Park |
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| State: Texas |
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| Zip: 78613 |
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Web Site: http://www.hirefighters.com
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