Assoc Spec, Clinical Research - BD Advanced Patient Monitoring

Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com  

Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

How you will make an impact:

• Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit), as well as study execution and closure activities.
• Organize and manage documents in the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) to ensure compliance with internal procedures. Review clinical data for completeness across multiple research trials and conduct thorough documentation reviews for internal and external audits (e.g., FDA, TUV, PMDA) to ensure all essential Trial Master File (TMF) documents adhere to Good Documentation Practices, internal SOPs, and relevant US and OUS regulations.
• Provide support across teams during study lifecycle, investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout
• Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
• Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
• Other incidental duties

What you will need: (Required)

• Bachelor's Degree or equivalent in Life Sciences or Nursing plus one year experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry.

What else we look for: (Preferred)

• Experience with electronic data capture 
• Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Good knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Good understanding of regulatory submissions, reporting, and audits
• Good problem-solving and critical thinking skills
• Strict attention to detail
• Ability to manage confidential information with discretion
• 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 immediate supervisor and other team members in the section or group
• 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 (CA) the base pay range for this position is $67,000 to $96,000 (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.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions req