Associate - Clinical Research
Job Requisition #: 11470
Date Posted: 07/29/2011
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 this position open in St. Paul.
Job Overview
Position Summary:
Under supervision of the Clinical Manager, the Senior Clinical Research Associate position manages the planning, designing, and execution of high quality clinical studies to ensure safety and effectiveness of SJM products. Ensures compliance to applicable regulatory standards. Focus is on study management activities and oversees monitoring of investigational centers.
Essential Functions:
Assists with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools.
Reviews and approves site activation documentation
Participates in site qualification and site initiation process, including scheduling of monitor activities with site personnel.
Assists in planning and preparing materials for investigator and coordinator meetings.
Assists in training of investigators and coordinators.
Tracks and reports progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events.
Coordinates and conducts monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, query generation and resolution, device accountability, and writing of monitoring visit reports
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.
Assist with core lab data management.
Assists with preparation of study summary reports for presentations, publications and regulatory submissions for FDA (510(K), IDE/PMA).
Assists with the development and implementation of site corrective actions as needed to address any noncompliance issues.
Assumes study management responsibility for smaller studies.
Has technical knowledge of product.
Writes and/or provides input to the monitoring plan.
Supports all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Qualifications:
Bachelors degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
2-5 years experience directly supporting clinical research or similar experience in a medical/scientific area.
Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.
High attention to detail and accuracy.
Advanced written and oral communications skills.
Able to manage multiple tasks.
Knowledge of clinical and outcomes research study design
Proficient knowledge of medical terminology.
Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
Good problem-solving skills.
Knowledge of clinical and outcomes research study design.
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 may be required.
Current drivers license
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