POSITION: Sr. Clinical Safety Specialist 
FULLTIME: 12-month Assignment
LOCATION: Remote
SCHEDULE: 6am-2:30pm
PAY RANGE: $45-$60/HR
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

JOB DESCRIPTION:
The Senior Clinical Safety Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.

Responsibilities will include:
 Manage adverse event processing including report review, safety query management, and expedited reporting
 Assess type/level of processing to be done for adverse events
 Author study specific safety documents and plans (e.g.: safety plan, CEC/IMR Charter, etc.)
 Acting member of clinical core team
 Conduct Clinical Trial Safety Review meetings
 Ensure adjudication and reconciliation of safety events are completed prior to data snapshots
 Provide safety-related input to other study documents/processes as requested (e.g.: protocol, CRF design, etc.)
 Manage functional deliverables to ensure study milestones are not delayed
 Management of additional projects, deliverables, and timelines to support additional activities within the clinical department

Quality System Responsibilities:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:

Required qualifications:
 Minimum bachelor’s degree or equivalent experience in science-related field
 Minimum 5 years clinical trial experience within role of safety required
 Proven or prior experience with clinical trial safety
***Medical device background

Preferred qualifications:
 Therapeutic knowledge in Urology
 Knowledge of GCP
 Experience with processing and assessing safety events and medical narrative writing
 Clinical database and systems

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