|
|
| Company: |
Nationwide Talent Source |
|
| Job Title: |
Clinical Research Associate |
| Job category: |
Research/Development |
| Job Location: |
WA Washington - USA |
| Job Reference Number: |
JB3236 |
| Job Description: |
Basic Job Info
Job ID 3236
Job Title Clinical Research Associate
Employment Status Full Time (Permanent)
Industry Consumer Products
Job Type Professional
Date Opened 11/18/2008
Job Status Accepting Resumes
Number of Openings 1
Location
Country United States
City Snoqualmie
State WA
Zip 98065
Pay relocation Costs Yes
Compensation
Pay Structure Salary plus Bonus and/or Commission
Base Salary Low $90,000.00
Base Salary High $115,000.00
Total Compensation Low $90,500.00
Total Compensation High $130,000.00
Experience Level
Level Mid (6 to 10 years)
Education
Level Major/ Majors Preferred/ Required
Undergraduate (Ba / Bs) Required
My client is a $35B world leader of medical devices, lighting, and consumer electronics products with a need for a Clinical Research Associate to join their Oral Healthcare division in Seattle, WA.
The Clinical Research Associate (CRA) coordinates clinical studies with outside partners such as dental professionals or research sites and universities in support of product development and substantiation of marketing claims. The CRA represents the department on project teams in support of new product development and product life cycle support. The essence of the role is to understand the need for clinical insights and translate them, in a meaningful way, back to the busines to develop outstanding products. Qualified candidates will have excellent project management skills in addition to their clinical research experience in medical device, pharma, or other life sciences.
Essential Responsibilities:
- Define & align the objectives / goals of clinical studies:
• Interact with project team to develop marketing claim requirements
• Align study objectives and timing with project team, marketing, legal counsel and clinical personnel- Select sites for clinical studies:- Organize, monitor, and report on clinical studies
• Initiate and organize clinical studies supported by external vendors
• Negotiate study contract & write study protocol
• Support preparation of the study and monitor progress and timelines
• Interpret statistical analysis of study & write and/or review, study-related documents- Manage and monitor clinical study budget:- Project Lead:
• Attend regular meetings with project teams to define and develop the scope of C&SA contribution in creation of new products and support of existing products.
• Communicate and organize C&SA activities in support of project teams/product development
Experience Required:
5+ years of these Clinical Research Competencies:
• Communication skills (interact with project leads from R&D & marketing on function development and claim requirements)
• Writing skills (study related documents, protocols, reports, etc.)
• Regulatory requirements knowledge - US, UK, EU, IRB, ADA, OSHA/WSHA, HIPAA
• Basic clinical and statistical study design principles
• Oral pathophysiology, microbiology, biomarkers
• Quality management and GCP
• Screen and select new external vendors/Investigators
• Literature search and review
• Web-based data collection applications, knowledge of key areas of Compliance
Non-Clinical duties and experience:
• Relationship Skills - Build and maintain relationships with dental professionals, research sites, including universities and external vendors, internal stakeholders. Build and maintain relationships with project stakeholders (R&D, Marketing, Operations, etc)
• Presentation Skills - Present findings to internal stakeholders, external collaborators
• Communication Skills - Act as study monitor and single point of contact and investigator; submit monthly reports to Director. Work cross-functionally within the organization to develop and meet deliverables
• Influencing Skills - Work with investigators on ensuring clinical plan is on schedule. Work with project team to align on clinical objectives
• Negotiation Skills - Negotiate contracts with sites and investigators, director, Clinical Operations to approve
• High-capacity multi-tasking, ability to prioritize and function effectively and quickly on multiple projects
• Critical thinking and Interpretive skills - view CSA as an extension of the larger business, work proactively to understand the context of the CSA deliverables, network within and outside the company as appropriate
Base salary range 95-115k + 15% annual bonus. Relocation to Seattle is provided
|
Language Requirements: |
|
| Employment Type: |
Full Time |
| Yearly Salary: |
90000 USD |
| Posting Date: |
2008-11-20 |
| Level of Education: |
Bachelor |
| Years of Work Experience: |
7 to 10 Years |
| Company: |
Nationwide Talent Source |
| Contact Name: |
Nationwide Talent Source |
| Contact Phone: |
2817036233 |
| Preferred Method of Contact: |
No Preference |
| Preferred Language of Resume/Application: |
English |
|
|
|
