FSP Sr. CRA - Ophthalmology - Remote US

Fortrea•Washington, DC
•$130,000 - $142,000•Remote

About The Position

The FSP team is seeking experienced Senior Clinical Research Associates (CRAs) with at least three years of clinical monitoring experience and ophthalmology expertise. The role involves applying clinical research skills, knowledge, and judgment to help protect clinical trial participants and respond to emergencies in accordance with clinical research standards. The position is open to candidates in major hub locations in California, Texas, and the South East and North East United States. The Senior CRA monitors and manages study sites, supports registry management, reviews clinical data, and completes safety reporting. The role also involves coordinating with vendors and study teams, training new employees, and potentially serving as a local project coordinator or client contact. Work takes place in an office environment and includes frequent travel to client or site locations, with occasional domestic and international travel. The target pay range is $130,000–$142,000.

Requirements

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (for example, nursing licensure).
  • At least 3 years of clinical monitoring experience.
  • Ophthalmology experience.
  • Ability to travel overnight 30–50% or more.
  • Comfort working in a fast-paced, technology-based environment with changing priorities, strict study-protocol requirements, and timelines.
  • Teamwork and people skills.

Responsibilities

  • Manage all aspects of study site monitoring, including routine monitoring and site close-out, study-file maintenance, and pre-study and initiation visits.
  • Liaise with vendors and perform other assigned duties.
  • Manage sites in accordance with project plans.
  • Conduct general on-site monitoring.
  • Ensure study staff receive the materials and instructions needed to enroll patients safely and according to the protocol.
  • Protect study participants by verifying that informed-consent procedures and protocol requirements comply with applicable regulatory requirements.
  • Verify the integrity of data submitted on Case Report Forms (CRFs) and other data collection tools through careful source-document review, and monitor for missing or implausible data.
  • Manage registry activities in accordance with project plans and undertake feasibility work when requested.
  • Complete Serious Adverse Event (SAE) reporting, prepare reports and narratives, and follow up on SAEs.
  • Independently review CRFs and generate and resolve queries according to established data-review guidelines using Fortrea or client data-management systems, as assigned.
  • Assist with training new employees, including through co-monitoring.
  • Coordinate designated clinical projects as a Local Project Coordinator, with supervision where applicable, and act as a local client contact when assigned.
  • Perform other duties assigned by management.
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