Clinical Research Specialist

Apply by eMail:do_not_reply@invalidemail.com

Description:
 
At ev3 we’re committed to developing innovative endovascular technologies for coronary, peripheral and neurological applications.  Creative, competent people with a passion for enhancing healthcare around the globe have driven our success.  Join us as we grow by making a meaningful difference. 
 
The Clinical Research Specialist is responsible for managing all or parts of a clinical study, satisfying applicable regulatory standards and company requirements.  This position should be able to assist in the development of clinical study protocols and writing of reports with minimal oversight.
 
MAIN RESPONSIBILITIES
 
Provide study management with moderate oversight as the Project Leader and assure successful conduct of assigned clinical studies consistent with the Clinical Strategy and applicable regulations and policies.  This includes interfacing with representatives from key functional groups including Clinical Affairs, Monitoring, Quality Affairs, Manufacturing, Sales, Marketing, Customer Service, Regulatory Affairs, R&D, and European Clinical Groups.
Work with the Director, Clinical Affairs or Clinical Research Manager to determine study objectives, strategy, scope and schedule in order to meet business needs.
Work with the Director, Clinical Affairs or Clinical Research Manager throughout all phases of the trial to ensure agreement on design, endpoints, milestones, progress and final submission.
Assist in the development of the Investigational Plan / protocol in consultation with the cross-functional project team, investigators and the clinical team.
Support clinical interface with regulatory agencies, including pre-IDE meetings with the FDA and presentations to FDA panel reviewers regarding clinical requirements and results of the study.
Responsible for development of CRF’s.
Responsible for device control and allocation for clinical sites.
Coordinate and oversee DSMB/CEC meetings.
Provide direction to and oversee outside CRO(s) / core laboratories associated with a trial to ensure adherence to contract, deliverables, data collection and other trial associated activities.
Participate in Investigator and site selection process.  Interface with, and assures training of, investigators, center staff, field monitors and ev3 clinical staff.
Provide direction to CRA I/II assigned to trial to ensure all activities are being performed according to DOP and study requirements.  Ensure adequate monitoring is conducted on all clinical trials and issues resolved in a timely fashion.
Coordinate efforts in data validation and database closure, supporting the efforts of the biostatistician and data base administrator.
Enlist support and specify tasks for various clinical team members to assure meeting study objectives on schedule.
Responsible for the review, compilation, and reporting of published literature and presentations on company products, including Clinical Data Evaluations. 
Evaluate clinical data / information with interim and final reports, convening and directing investigator conferences to review findings and advise on direction.
Provide input and support for planning post-clinical activities, submissions and market launch of products.
Represent the clinical department in ev3 Endovascular Inc. Product Hazard Analysis and Risk Analysis activities.
Responsible for managing the budget for assigned clinical trials. Provide budget input for new trials.
Acquire professional, product and market expertise via independent reading, networking and training.
Comply with applicable FDA and international regulatory laws / standards, the ev3 Code of Conduct, including company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs).
 
BASIC QUALIFICATIONS
 
Bachelor’s degree in Engineering, Biological Sciences or related medical/scientific field
3+ years’ experience directly supporting clinical research or similar experience in a medical / scientific area.
Expertise with GCPs and regulatory compliance guidelines for clinical trials
 
PREFERRED QUALIFICATIONS
 
Master’s degree with 2+ years’ experience or PhD / MD with 1 or more year’s experience
 
POSITION REQUIREMENTS
 
Knowledge of clinical and outcomes research study design, methods and statistics
Proficient knowledge o...

Apply by eMail:do_not_reply@invalidemail.com

Job Created: Tue Oct 27 2009 06:57:55 AM
Last Modified: Sat Nov 21 2009 07:09:28 AM