Clinical Research Specialist, AT

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team within, Advanced Technologies, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes and ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. As the Clinical Research Specialist, you will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

The position will be on-site at our Irvine headquarter and a hybrid working schedule can be discussed after the training period.

You will make an impact by...
• Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
• Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
• Other incidental duties
 

What you'll need (Required):

• Bachelor's Degree or Equivalent in Life Sciences or Nursing

• 3 year's experience in clinical research (site management, clinical project management, monitoring, and/or CRC) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry

• Experience in electronic data capture

• Covid Vaccination

• Ability to travel up to 25% for site visits, conferences, investigator meetings, with some potential global travel, as needed

What else we look for (Preferred):

• Experience working in a medical device or regulated industry

• Computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred

• Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills are required

• Strong problem-solving and critical thinking skills

• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise

• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols

• Moderate understanding of regulatory submissions, reporting, and audits

• Ability to manage confidential information with discretion

• 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 representing the organization on specific projects

• Ability to build productive internal/external working relationships

• 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 $81,000 to $114,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).