Clinical Research Associate
Location: Burlington Vermont
Description: DOCS is currently interviewing Clinical Research Associate right now, this career will be placed in Vermont. Further informations about this career opportunity kindly see the descriptions. Seeking experienced monitor with Cardiovascular Device experience to work with a leading device company!
The Role and your Responsibilities
The Clinical Research Associate is responsibl! e for establishing, managing and meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with sponsor business needs. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical and business requirements are met.
Position Responsibilities
. Follow all work/quality procedures to ensure quality system compliance and high quality work.
. Provides project and study management and assures successful conduct of assigned clinical studies. This includes interfacing with representatives from key functional groups including Field Clinical Engineering, Database Administration/Data Management, Statistics, Clinical Quality, Reimbursement, Regulatory Affairs, Marketing, International Clinical Groups, and Product Development (as needed).
. Drives process to determine study objectives, strategy, scope, and schedule in order to meet business needs; ! may include development of global clinical strategy.
. Est! ablishes selection criteria for principal investigators and investigative sites and drives center selection process.
. Responsible for site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
. Responsible for site monitoring (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and sponsor standards, guidelines and policies.
. Prepare accurate and timely monitoring reports to study management and follow action items through resolution.
. Ensure accurate inventory accountability of investigative product at clinical sites
. Ensures site activities in line with milestones (i.e. startup, recruitment, closeout, etc) and implement contingency plans as needed
. Responsible for accurate and time! ly adverse event reporting during the study.
. Will ensure site adherence to FDA, Regulatory, IRB and sponsor requirements.
. Work with investigators to quickly and effectively resolve problems.
. Evaluates clinical data/information and prepares interim and final reports.
. May develop study budget and manage study spending to plan.
What is Required
- Nursing degree or similar medical professionals with at least 5 years' experience with specific experience in Coronary Medical Devices
Ability to travel up to 50%
What is Offered
DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients.
We offer competitive salary, comprehensive benefits including paid days off, 401K, and health insurance.
You are an experienced CRA seek! ing a new project with a stable organization. You have the ability to travel and understand the complexity of monitoring cardio device trials.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to DOCS.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Fri, 31 May 2013 15:45:35 GMT
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