Ophthalmology & Biopharma - CRA II & Sr. CRAs

Role Summary

Experienced Ophthalmology & Biopharma CRAs to lead and support our Full Service Outsourcing team. Open to major hub locations on the East & West Coast. 60-70% travel, 8-10 DOS per month. The role involves monitoring study sites, ensuring protocol compliance, safeguarding participant safety, and supporting data integrity and project coordination.

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 by detecting 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, e.g., 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.