CRA II & Sr. CRA - Ophthalmology & General Medicine
Salary$105k – $140k
Location23 Locations
Work moderemote
Typefull-time
Company size10,000+ people
First seen1w ago
Last seen2d ago
We are currently seeking Experienced Ophthalmology (Sr CRAs & CRA 1/2) to lead and support our Full Service Outsourcing team. Open to major hub locations within the United States. 60-70% travel, 8-10 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:
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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 -
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Responsible for all aspects of site management as prescribed in the project plans
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General On-Site Monitoring
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Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
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Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
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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
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Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
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Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
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Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
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Assist with training of new employees, eg. co-monitoring
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Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
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Perform other duties as assigned by management
Requirements
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University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
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1-3 years of Clinical Monitoring experience
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Open to various hub locations
The important thing for us is you are comfortable working in an environment that is:
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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.
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Changing priorities constantly asking you to prioritize and adapt on the spot.
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Teamwork and people skills are essential for the study to run smoothly.
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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: