Ophthalmology & Biopharma - CRA II

Role Summary

Ophthalmology & Biopharma CRA II responsible for leading and supporting a Full Service Outsourcing team with a focus on ophthalmology trials. Open to major hub locations on the East & West Coast, with 60-70% travel and 8-10 days on site per month.

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 monitoring and data review 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 reports, 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

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1-3 years of Clinical Monitoring experience
• Ophthalmology experience is desired
• Open to various hub locations

Skills

• Ability to work in a fast-paced environment with strict adherence to study protocol and timelines
• Adaptability to changing priorities and strong teamwork and communication skills
• Technology-savvy; experience entering data directly into an electronic data capture environment

Education

• Details not specified beyond degree/certification requirements in Qualifications

Additional Requirements

• Frequent travel to clients/site locations with occasional domestic and international travel
• Physical requirements include ability to sit for extended periods, light to moderate lifting, and standard computer use