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:
* 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, if applicable) and may act as a local client contact as assigned
* Perform other duties as assigned by management
Requirements
* 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
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) – Flex Plan
* Employee recognition awards
* Multiple ERG’s (employee resource groups)
* Target Pay Range (based on title): $105-140K
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 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 - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here
[https://careers.fortrea.com/us/en/eeo-and-accommodations].