• Provide assurance that adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards to ensure patient safety in clinical trials.

• Provide oversight on all safety processes from the site to the CEC to ensure process flow is managed efficiently and effectively

• Develop training programs and metrics for safety team knowledge in collaboration with management to optimize the application of knowledge and performance

• Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site

• Develop and write medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures

• Educate and provide training to enrolling sites to ensure protocol requirements are followed

• Provide guidance and direction to lower-level staff

• Other incidental duties

What you’ll need (required):

• Master's Science Nursing (MSN Degree), Biological or Lifesciences field or related Plus 3 years of previous hands-on clinical research related experience Required or

• Bachelor's Science Nursing (BSN) Biological or Lifesciences field or related Plus 5 years of previous hands-on clinical research related experience Required 

What else we look for (preferred):

• Master's Degree or equivalent in Related field

• Experience with an ERP software, CTMS (Clinical Trial Management System) and Patient Tracking system Preferred or

• Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred

• Ability to gain full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies

• Full understanding of medical terminology as it relates to clinical safety

• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)

• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery

• Ability to manage confidential information with discretion

• Excellent written and verbal communication skills and interpersonal relationship skills

• Demonstrated problem-solving and critical thinking skills

• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $106,000 to $149,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.