C. R. Bard, Inc.

Clinical Safety Specialist I

2 weeks ago
Industry / Category
Clinical Safety Specialist I
Job ID
2017-10853
Career Level
experienced
Division
New Hope, MN / Lutonix
Relocation
No
US-MN-New Hope

Summary of Position with General Responsibilities

The Clinical Safety Specialist I coordinates and supports clinical study adverse event data collection, assessment, adjudication and analysis.

Essential Job Functions

 

  • Provide initial review, evaluation, and track incoming adverse events for assigned studies,
  • Escalate events as appropriate per study specific safety plan to designated recipients,
  • Assist in collaboration with Regulatory Affairs, Clinical Study Teams , and Medical Monitor on events requiring expedited review or reporting.
  • Work with Field Assurance to ensure timely reporting of AEs, SAEs and UADE’s, in accordance with applicable regulations and company procedures,
  • Support additional safety-related tasks (e.g. Medical Monitor reports for aggregate trend review and signal detection) as directed,
  • Ensure consistency and compliance in applications of definitions for adjudication outcomes across assigned studies as appropriate for the specified protocols,
  • Provide support in preparing and coordinating CEC / DMC / DSMB meetings, or working with CROs who oversee this function, as applicable
  • Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.

Basic Qualifications

 

  • Bachelor’s degree or equivalent experience;
  • At least 2 years of clinical research experience, ideally with 1 year clinical safety responsibilities;
  • Working knowledge of the pharmaceutical, biotechnology and/or medical device clinical trial data management and processes, including the regulatory requirements of 21 CFR Part 11, ICH-GCP, other relevant Guidance documents (ICH, FDA, EMA etc.).

Additional Desirable Qualifications Skills and Knowledge

  • Experience in cardiovascular field
  • Familiarity with multiple EDC systems
  • Knowledge and working familiarity of MedRA coding and safety management systems (eg. AERS, ARGUS)
  • Working knowledge of medical terminology, acronyms, and ability to communicate effectively with medical personnel.
  • Strong Microsoft Office skills, including Excel, Word, and Power Point.

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.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed