Sr. Clinical Safety Specialist (Remote)
Sr. Clinical Safety Specialist (Remote)
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Salary Not Disclosed
1 Vacancy
Job Description
POSITION: Sr. Clinical Safety Specialist
FULLTIME: 12month Assignment
LOCATION: Remote
SCHEDULE: 6am2:30pm
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 projectspecific safety plans as well as overseeing event and complaint processing in accordance with studyspecific 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 safetyrelated 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 bachelors degree or equivalent experience in sciencerelated 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 everchanging 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
Required Experience:
Senior IC
Employment Type
Full Time
