FSP Sr. Clinical Research Associate II - Northeast - Ophthalmology

Fortrea; San Francisco (CA); A distancia; USD 125.000 - 142.000; Jornada completa

Descripción de la vacante

Fortrea is seeking Ophthalmology or Oncology Sr. CRAs with 4+ years of monitoring experience to service clients in the Northeast area. This role involves extensive site monitoring, data verification, SAE reporting, and collaboration with cross-functional teams.

Responsibilities include site management, ensuring protocol adherence, training staff, and coordinating project activities. Expect 30–50% overnight travel and a fast-paced environment demanding strict timeline compliance.

Formación

• Bachelor's degree or certification in a related allied health profession.
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• 30-50% overnight travel.

Responsabilidades

• Monitor all aspects of site monitoring including routine visits and close-out, maintain study files, and initiate visits.
• Manage site activities per project plans and liaise with vendors.
• Oversee general on-site monitoring and ensure staff have proper materials.
• Verify informed consent procedures and protocol requirements per regulatory standards.
• Ensure data integrity on CRFs and data collection tools.
• Monitor data for missing or implausible values.
• Handle registry management and conduct feasibility work as requested.
• Complete SAE reporting and narratives with follow-up.
• Perform CRF review and issue resolution per data guidelines.
• Assist with training of new staff and co-monitoring.
• Coordinate clinical projects as Local Project Coordinator and serve as client contact when assigned.
• Perform other duties as assigned by management.

Conocimientos

Clinical Monitoring

Oncology experience

Clinical trial operations

Educación

University degree or allied health certification

Descripción del empleo

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

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#LI - Remote

Learn more about our EEO & Accommodations request here.