Medical Device & Diagnostics - CRA 2 - US Remote

Benefits

Qualifications

• •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 locations
• •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
• •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
• •Remote
• •12 more items(s)

Responsibilities

• •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
• •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
• •Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• •Perform other duties as assigned by management
• •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
• •12 more items(s)