Clinical Safety Specialist

Job Description

Primary Function of Position:

The position of Clinical Safety Specialist requires a strong candidate with experience in clinical research trial design and management as well as medical writing.  The position will mainly focus on the development and implementation of Safety Monitoring Protocols in support of clinical studies.  The purpose of this job is to establish the safety and efficacy of existing and investigation medical devices through the determination of whether the investigational product presents an unreasonable and significant risk to clinical study participants.  One of the most important aspects of the position is to evaluate, analyze, and report (via written safety narratives) every adverse event that is experienced by an individual in a clinical trial.  The position will collaborate with various groups both outside of and within Intuitive, including, but not limited to, Clinical Affairs / Medical Affairs, Data Monitoring Committees, Investigators, Compliance Regulatory Affairs, Regulatory Agencies, Clinical Developmental Engineering, and Regulatory Post-Market Surveillance.

Roles and Responsibilities:

This position has the responsibility and authority for:

·         Acquire or possess in-depth knowledge of Investigational Device Exemptions clinical studies.

·         Acquire or possess in-depth knowledge of adverse device effects, serious adverse device effects, and unanticipated adverse device effect reporting criteria.  Assist in the investigation and review of all Adverse Events, Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Unanticipated Adverse Device Effect for determination of adjudication and/or regulatory reporting.

·         Evaluate and investigate clinical scenarios and help to determine participant risk that may be associated with the clinical study.   Ensure that event data received from Investigators is complete and accurate.

·         Collaborate with in a cross-functional team in the research protocol development to help inform the study objective, trial design, study population, including the selection criteria (inclusion and exclusion criteria to ensure patient safety while optimizing the potential to achieve study endpoints), methods to assure consistency and monitoring, and ethical considerations.

·         Ensure that records related to adverse device effects (whether anticipated or unanticipated) and complaints are accurate, complete, and current in accordance with 21 CFR 812.140(b).

·         Collaborate with in a cross-function team in development of the requirements of the Data Monitoring Committee (DMC) members or Data Safety Monitoring Board members (DMSB), if required by the study protocol.  Participate in the selection process of the DMC and/or DMSB committee members.  Establish protocols that ensure accurate, complete, and timely data evaluations to access the progress of a clinical trial toward the study endpoints while maintaining clinical trial safety.

·         Coordinate regular and timely interactions between Intuitive and Data Monitoring Committee (DMS) or Data Safety Monitoring Board (DMSB) to evaluate clinical trial progress.

·         Establish protocols to standardize the safety monitoring process.

·         Ensure that all safety-related inquiries from regulatory bodies, DMCs / DSMBs, and other external bodies are thoroughly addressed in a timely manner.

·         Establish and maintain safety monitoring database for clinical trial tracking of Adverse Events, Serious Adverse Events.  Establish, track, and trend clinical safety performance metrics.  Develop reporting tools to demonstrate clinical safety performance.

·         Educate and train the Investigation team on the research protocol, including inclusion and exclusion criteria, expected timeline reporting for adverse device events, serious adverse device events, and unanticipated adverse device events, data collection, and case reporting (completion of Case Report Forms (CRFs)).

·         Prepare complete, accurate, and timely reports as required all identified reports to ensure compliance with all regulatory requirement (e.g., GCP, US and OUS Guidelines) such as the following examples:  Unanticipated Adverse Device Effects reports, Withdrawal of IRB and/or FDA Approval reports, Progress Reports, Final Reports, and any other reports about any aspect of the investigation upon request of a regulatory agency and/or IRB.

·         Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US an OUS Guidelines).

·         Assist in the preparation of the Summary of Safety and Effectiveness Data which may include a summary of the clinical studies and conclusions drawn from the studies such as Safety and effectiveness and benefit-risk analysis

Qualifications

Skill/Job Requirements:

Competency Requirements: (Competency is based on education, training, skill and experience.)  To adequately perform the responsibilities of this position the individual must:

·         Previous experience in the application of in-depth therapeutic and device knowledge to develop Safety Narrative Reports and Annual Reports

·         Must have a minimum of 5 – 8 years of medical writing experience

·         Minimum of 2-4 years of experience in clinical research experience

·         Ability to identify critical information needs and identify roles / individual to involve for decision making within the clinical investigation safety assessment and safety narrative report development

·         Demonstrated ability to communicate verbally clearly and effectively and in technical or scientific writing; demonstrated effective scientific writing skills.  (Replace with the term clinical)

·         Excellent critical and analytical thinking skills.

·         Master of Science in Nursing, MD, or PhD degree is desired.

·         Must be able to work effectively on cross-functional team.

·         Must be able to manage multiple projects across numerous surgical disciplines.

·         Strong communication, presentation, and interpersonal skills with high attention to detail and organization.

·         Strong experience in protocol development, writing clinical case reports, clinical papers, and safety narratives.

·         Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures.

·         Consistently shows dedication or strong work-ethic.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.