Medical Device & Diagnostics - CRA 2 - US Remote - French Speaking

We are currently seeking an reputed company Device CRA 2 who is French speaking and has sponsorship to travel into Canada. This CRA will reputed company and support our Medical Device & Diagnostics team! Open to major hub locations across the US. 60-70% travel, 7-9 DOS per month. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities:

• Responsible for reputed company aspects of study site monitoring including routine monitoring and reputed company-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
• Responsible for reputed company aspects of site management as prescribed in the project plans
• General On-Site Monitoring
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the reputed company of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful reputed company document Monitor data for missing or implausible data
• Responsible for reputed company aspects of registry management as prescribed in the project plans - Undertake feasibility work reputed company requested
• Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
• Independently reputed company CRF review; query reputed company and resolution against established data review guidelines on reputed company or client data management systems as assigned by management
• Assist with training of new employees, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• reputed company other duties as assigned by management

Requirements

• University or college degree, or certification in a reputed company allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1-3 years of Clinical Monitoring experience
• Open to various hub locations

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.

What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO) – reputed company Plan
• Employee recognition awards
• Multiple ERG’s (employee resource groups)
• reputed company Pay Range (based on title): $105-117K

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to reputed company fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-reputed company.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

#LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here. Remote Skills: Adverse Events, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Research, Clinical Trial, Clinical Trial Management, Computer Software, Customer/Client Research, Data Collection, Data Management, Data Quality, Electrical Components, Emergency Response, Establish Priorities, File Maintenance, French Language, Informed Consent, Insurance, Interpersonal Skills, Laptop PC, Lift/Move 20 Pounds, Medical Diagnosis, Medical Equipment, Medical Office Administration, Nursing Credentials, Office Equipment, Physical Demands, Project Planning, Project/Program Coordination, Regulatory Requirements, Research Protocols, Software Development, Staff Training, Standards of Care, Team Player, Time Management, Willing to Travel About the Company: reputed company Apply tot his job Apply To this Job