Clinical Safety Specialist

FULLTIME: 12-Month Assignment

LOCATION: REMOTE

SCHEDULE: 30-40 Hours Per Week

PAY RANGE: $38/HR
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

JOB DESCRIPTION:
• Support the collection, review, reconciliation, and documentation of adverse events (AEs), serious adverse events (SAEs), device deficiencies, and other reportable clinical safety information from clinical studies.
• Perform initial review of clinical safety data for completeness, consistency, and potential safety concerns and facilitate appropriate follow-up with study teams and clinical sites.
• Coordinate safety-event workflows to support timely medical assessment, event classification, reporting, and closure.
• Partner with Medical Safety/Medical Affairs personnel to facilitate medical review of adverse events, including assessments of seriousness, relatedness, expectedness, and potential device or procedure relationships, as applicable.
• Support preparation and submission of safety reports and notifications in accordance with applicable regulatory requirements, clinical study plans, and internal procedures.
• Monitor safety data and contribute to the identification, documentation, and escalation of potential safety signals or emerging clinical risks.
• Support periodic and aggregate reviews of clinical safety data, including preparation of safety summaries, trend analyses, listings, and metrics.
• Perform safety-data reconciliation across clinical databases, safety systems, complaint systems, and other relevant data sources.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, Medical Affairs, and other functions to resolve safety-data discrepancies and maintain accurate clinical records.
• Support development and maintenance of clinical safety plans, procedures, work instructions, study documents, and other safety-related documentation.
• Provide safety-related input into clinical study documents such as protocols, case report forms, informed consent materials, clinical reports, and risk-management documentation, as appropriate.
• Support safety activities associated with Data Monitoring Committees, Clinical Events Committees, or other independent review committees, when applicable.
• Maintain inspection-ready documentation and support internal audits, regulatory inspections, and responses to safety-related questions.
• Track safety deliverables, timelines, and key performance indicators and proactively identify risks to timely completion.
• Participate in continuous-improvement initiatives designed to improve the quality, consistency, and efficiency of clinical safety processes.
• Maintain current knowledge of relevant medical-device clinical safety regulations, standards, guidance, and internal requirements.

Education/Experience/Skills required to successfully perform the above duties/tasks:
• Bachelor's degree in nursing, life sciences, biomedical sciences, healthcare, engineering, or a related discipline
• 3 years experience within role of safety
• Proven or prior experience with clinical trial safety
• Strong attention to detail with the ability to evaluate complex clinical information and maintain accurate documentation.
• Strong organizational and prioritization skills with the ability to manage multiple activities and deadlines.
• Effective written and verbal communication skills.
• Demonstrated ability to collaborate effectively within cross-functional teams.
• CRO Management experience
• US and international regulations experience as it pertains to conducting pre and post-market clinical studies
• Good Clinical Practice

Preferred qualifications:
? Fluent in English
? Therapeutic knowledge in Interventional Cardiology
? Experience within the medical-device industry
? Knowledge of GCP
? Experience with processing and assessing safety events and medical narrative writing
? Experience with BfArM and EU Regulatory Safety reporting
? Strong clinical database and systems knowledge (preferably Medidata RAVE)

WORKING CONDITIONS:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs
• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The pay range for this position is listed above. Base pay information is based on market location.
We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.
For individuals with disabilities who would like to request an accommodation, please email hr@canonrecruiting.com