FSP Sr. Clinical Research Associate II - Northeast - Ophthalmology

Fortrea; Providence (RI); Remote; USD 125.000 - 142.000; Vollzeit

Zusammenfassung

Fortrea seeks an Ophthalmology or Oncology Senior Clinical Research Associate with 5+ years of monitoring experience, based in the Northeast. The role covers site monitoring, data integrity, SAE oversight, and project coordination with travel 30–50%.

You will conduct site visits, manage regulatory compliance, train staff, and liaise with vendors while ensuring patient safety and data quality in complex trials. Remote/hybrid options may be available.

Qualifikationen

• 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.
• 30-50% overnight travel.

Aufgaben

• 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
• 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
• Independent 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

Kenntnisse

Clinical monitoring

Site management

Data quality

Vendor liaison

Training support

Ausbildung

University or college degree or allied health certification

Tools

Clinical data systems

Source data verification

Jobbeschreibung

Our FSP team is currently seeking Ophthalmology or Oncology Sr. CRAs with 4+ years of monitoring residing in the Northeast area.

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

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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