FSP Sr. Clinical Research Associate II - East Coast - Ophthalmology

Fortrea; Williamstown (NJ); A distancia; USD 125.000 - 142.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Travel opportunities

Descripción de la vacante

Fortrea is seeking an Ophthalmology Sr. CRA with 4+ years of monitoring experience to support the East Coast US region. The role involves site monitoring, data integrity, and SAE reporting within a fast-paced clinical trial environment.

Travel will be 30-50% overnight, with responsibilities including site management, training, and collaboration with vendors and project teams. Oncology experience is preferred for early-phase trials.

Formación

• University or college degree, or certification in a related allied health profession (e.g. nursing licensure).
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.

Responsabilidades

• Monitor all aspects of study sites, including routine monitoring and close-out of sites and file maintenance.
• Conduct pre-study and initiation visits and liaise with vendors.
• Perform general on-site monitoring and ensure protocol staff have required materials and instructions.
• Verify informed consent procedures and protocol requirements per regulatory rules.
• Ensure data integrity on CRFs and other data collection tools; monitor data quality.
• Manage registry activities and perform feasibility work when requested.
• Complete SAE reporting and follow-up narratives as required.
• CRF review, query generation, and resolution per data review guidelines.
• Assist with training new employees or co-monitoring activities.
• Coordinate clinical projects as Local Project Coordinator and act as client contact when assigned.
• Perform other duties as assigned by management.

Conocimientos

Clinical Monitoring

Oncology experience

Travel readiness

Educación

University degree or allied health certification

Descripción del empleo

Our FSP team is currently seeking Ophthalmology Sr. CRAs with 4+ years of monitoring residing on the East Coast of the 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)
• 5+ years of Clinical Monitoring experience
• Oncology experience, early phase preferred
• 30-50% overnight travel

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: $125 - $142K

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