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

We are currently seeking an Experienced Device CRA 2 who is French speaking and has sponsorship to travel into Canada. This CRA will lead 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 DOYou 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 all aspects of study site monitoring including routine monitoring and close-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 all 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 integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data * Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested * Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs * Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea 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, ifapplicable) and may act as a local client contact as assigned * Perform other duties as assigned by managementRequirements * University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) * 1-3 years of Clinical Monitoring experience * Open to various hub locationsThe 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) - Flex Plan * Employee recognition awards * Multiple ERG's (employee resource groups) * Target Pay Range (based on title): $105-117KWork 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 make 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-shelf. * 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 - RemoteApplications will be accepted on an ongoing basis.Learn more about our .