C. R. Bard, Inc.

Sr. Clinical Research Associate

2 weeks ago
Industry / Category
Senior Clinical Research Associate
Job ID
2017-10851
Career Level
experienced
Division
New Hope MN/Lutonix
Relocation
No
US-MN-New Hope

Overview

The Sr. Clinical Research Associate is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of clinical trials for Lutonix products. The Sr. CRA ensures that clinical tasks are being performed in compliance with all regulations, Good Clinical Practices, and company policies and procedures.   Under direction of the Clinical Trial Manager, the Sr. CRA may take on a leadership role in the conduct of the clinical trial.

Summary of Position with General Responsibilities

 

  • Plan and execute clinical studies ensuring that deliverables are completed on time and within budget
  • Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
  • Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
  • Participate in site qualification and initiation activities, including training of investigators and coordinators
  • Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
  • Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
  • Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance
  • Develop and implement site corrective actions as needed to address any noncompliance issues
  • Assist in planning, preparing, and presenting materials for investigator and coordinator meetings
  • Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
  • Participate in regular project team meetings
  • Maintain current working knowledge of the disease state and product
  • May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts
  • Oversee development and management of clinical database for the trial
  • Provide work direction and mentoring to internal and external team members as needed

 

Basic Qualifications

 

  • BA/BS or equivalent experience
  • 5 or more years of Clinical Research experience 
  • 3 or more years of monitoring experience
  • 1 or more years of medical device experience
  • Strong computer skills with a proficiency with MS Windows based applications
  • Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials; this includes ISO14155 for any trials conducted within the EU
  • Excellent communication skills (oral and written)
  • Strong organizational skills and able to manage multiple tasks
  • Ability to work independently and provide work direction to others
  • Previous experience with peripheral vascular devices preferred
  • Previous experience with EDC systems preferred  
  • Ability to work effectively on cross-functional teams preferred  
  • Valid driver’s license required
  • Able to travel 20% on average and up to 40% during peak periods    

 

 

Physical Demands

While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers.  The employee frequently is required to see, talk and hear.  The employee is occasionally required to bend, lift, reach or stoop.  Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.  Upon request, the company may make reasonable accommodations. 

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment. Employee must be able to work in a team-oriented, fast-paced environment.  Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

 

 

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