Our FSP team is currently seeking experienced Sr. CRAs with 3+ years of monitoring ! Ophthalmology expertise required. Open to major hub locations in California, Texas, and the South East & North East US!
What you will do
- 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)
- 3+ years of Clinical Monitoring experience
- 30-50+% overnight travel
- Ophthalmology experience
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.
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
Target Pay Range
$130 - $142K