Senior Clinical Research Associate
Job Requisition #: 11824
Date Posted: 10/07/2011
Category: Clinical
Location: St. Paul - MN - USA
About Us
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division:
Job Overview
The Senior Clinical Research Associate plans, designs, and executes high quality clinical studies to ensure the safety and effectiveness of SJM products. This role ensures compliance to applicable regulatory standards. The focus is on study management activities and monitoring of investigational centers.
Essential Functions:
Develops clinical protocols, case report forms, study manuals, in collaboration with Clinical Manager
Reviews and approves site activation documentation
Qualifies and initiates sites, including scheduling monitor activities with site personnel
Assists in planning and preparing materials for investigator and coordinator meetings in collaboration with Clinical Manager
Trains investigators and coordinators
Tracks and reports study progress, e.g. subject screening and enrollment, data collection, documentation of adverse events
Coordinates and conducts monitoring visits to ensure compliance to the clinical protocol, regulations and timely receipt of data
Oversees activities by CROs
Provides input to study budgets and project plans
Assists clinical manager by providing input to sections of the Investigational Plan, clinical reports, and abstracts/manuscripts
Manages smaller studies
Provide clinical scientific support to core development teams
Manage core lab data
Prepares study summary reports for presentations, publications and submissions
Develops and implements site corrective actions
Qualifications
Bachelors degree
5-7 years experience supporting clinical research
3 years experience monitoring sites
Knowledge of clinical and outcomes research study design
Proficient knowledge of medical terminology
Expertise with GCPs, and regulatory compliance guidelines for clinical trials
High attention to detail and accuracy
Advanced written and oral communications skills
Able to manage multiple tasks
Good problem-solving skills
Proficient computer skills (MS Office)
Demonstrated ability to work effectively on cross-functional teams
Able to travel 50% on average and up to 80% during peak periods
Current drivers license
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