FSP Sr. CRA - Ophthalmology - Remote US

Fortrea; Wisconsin; A distancia; USD 130.000 - 142.000; Jornada completa

Descripción de la vacante

Fortrea is seeking an experienced Senior CRA with ophthalmology expertise to lead clinical monitoring across sites in the US. The role requires 3+ years of monitoring experience, willingness to travel 30-50% and the ability to manage data integrity and regulatory compliance.

You will monitor sites, ensure proper informed consent, maintain study files, liaise with vendors, and support registry activities. Strong teamwork and adaptability are essential in this fast-paced environment.

Formación

• 3+ years of Clinical Monitoring experience.
• Ophthalmology experience.
• 30-50% overnight travel.
• Bachelor's degree or equivalent certification.

Responsabilidades

• Monitor clinical sites, conduct pre-study visits, initiate visits, and perform close-outs.
• Maintain study files and liaise with vendors as needed.
• Manage site monitoring activities per project plans.
• Ensure staff are trained with protocol materials and study procedures.
• Verify informed consent procedures comply with applicable regulations.
• Review CRFs and monitor data quality for missing or implausible data.
• Oversee registry management and conduct feasibility work as requested.
• Complete SAE reporting and prepare narratives and follow-up.
• CRF data review, query generation, and resolution per guidelines.
• Assist with training and coordinate local projects; act as a client contact when assigned.
• Perform other duties as assigned by management.

Conocimientos

Clinical Monitoring

Ophthalmology experience

3+ years experience

Educación

Bachelor's degree or related allied health certification

Descripción del empleo

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

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)
• 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

#LI - Remote