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

Fortrea; Hartford (CT); Remote; USD 85,000 - 142,000; Full time

Benefits offered by this job

Remote-friendly work

Travel opportunities

Job summary

Fortrea is seeking an Ophthalmology Senior CRA for monitoring across the East Coast of the United States. The role demands clinical judgement, strict protocol adherence, and timely SAE reporting.

Expect 30–50% overnight travel and frequent site visits to ensure patient safety and data integrity. The candidate should have 5+ years of clinical monitoring experience, oncology or early-phase exposure preferred, and a bachelor’s degree in a related allied health field.

Qualifications

• University or college degree in a related allied health field.
• 5+ years of Clinical Monitoring experience.
• Oncology experience and early phase experience preferred.
• 30-50% overnight travel.

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.
• Responsible for all aspects of site management as prescribed in the project plans.
• General On-Site Monitoring and patient entry safety verification.
• Ensure informed consent procedures and protocol adherence; data integrity of CRFs.
• Perform SAE reporting, narratives and follow-up of SAEs.
• Independently perform CRF review and data queries; training of new staff; coordinate projects as Local Project Coordinator.

Skills

Ophthalmology monitoring

Site monitoring

SAE reporting

CRF review

Training teammates

Local Project Coordination

Travel readiness

Education

Bachelor's degree in allied health

Tools

Clinical data management systems

CRF/data capture tools

Job description

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 plansGeneral On-Site MonitoringEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure 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 dataResponsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requestedComplete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training of new employees, eg. co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assignedPerform 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 Teamwork and people skills are essential for the study to run smoothly.

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

#LI - Remote

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