FSP Sr. CRA - Ophthalmology - Remote US

Job Title: FSP Sr. CRA - Ophthalmology - Remote US Job Location: Remote United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Our FSP team is currently seeking experienced Sr. CRAs with 3+ years of monitoring! Ophthalmology expertise required.

Open to major hub locations in California, Texas, and the South East & North East 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 Co