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

Fortrea

Durham, NC(remote)

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JOB DETAILS
SALARY
$105,000–$117,000 Per Year
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
LOCATION
Durham, NC
POSTED
1 day ago
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 .

About the Company

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Fortrea

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