Regional Clinical Research Associate
Location: Salt Lake City Utah
Description: DOCS is looking of Regional Clinical Research Associate right now, this position will be placed in Utah. Further informations about this position opportunity kindly see the descriptions. We are an international CRO going through a major growth phase and we are looking to hire Clinical Research Associates in all therapeutic areas with at least five years of regional monitoring exp! erience.
Responsibilities
- Perform designated projects in accordance with applicable SOPs, clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
- Responsible for coordinating a moderate to large team or multiple small size protocols as the CRA, with minimal to no supervision. Alternatively, take on the role of a CRA on smaller projects.
- Act as an independent CRA on complex or multiple projects, CRA on smaller projects
- Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent company at professional meetings / conferences
- Function as mentor and role model for other CRA team member! s to ensure study specific training for CRAs
- Perform ! co-monitoring visits with less experienced CRAs or at problem sites as required
- Build relationships with investigators and site staff
- Participate in Investigator and other external or internal meetings as required
- Arrange on-site visits and logistics (e.g. travel arrangements)
- Perform on site visits in accordance with the monitoring plan
- Perform site facilities inspection
- Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
- Monitor and maintain ICH-GCP compliance
- Responsible for the completeness and quality of the on-site files
- Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
- Update all relevant tracking system on an ongoing basis
- Collaborate on site issues/actions
- Generate visit/contact report in accordance with monitori! ng plan
- Attend audits / Regulatory Inspection if requested
- Bachelor's degree (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
- Substantial monitoring experience or equal experience in clinical research
- Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
- Strong regulatory knowledge including GCP
- Excellent interpersonal, verbal and written communication skills
- Sound problem solving skills
- Ability to successfully work in a team environment
- Sound presentation skills
- Ability to solve problems by using a logical, systematic, sequential approach
- Client focused approach to work with the ability to interact professionally within a client organization
- Ability to prioritize multiple tasks and achieve project tim! elines
- Effective time management in order to meet daily metric! s or team objectives
- Shows commitment to and performs consistently high quality work
- Able to take initiative and work independently
- Able to travel up to 65%-75% on average
- Holds a driving license where required
- Competent in written and oral English
- .
If you were eligible to this position, please email us your resume, with salary requirements and a resume to DOCS.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Fri, 25 Oct 2013 00:30:14 GMT
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.