Ophthalmology & Biopharma - CRA II & Sr. CRAs

Role Summary

Ophthalmology & Biopharma CRA II & Sr. CRAs. Experienced CRAs to lead and support a Full Service Outsourcing team. Open to major hub locations on the East & West Coast with significant travel.

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, 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

Skills

• Clinical trial monitoring and regulatory compliance
• Data management and CRF review
• SAE reporting and narrative compilation
• Vendor liaison and project coordination
• Training and mentoring of new staff
• Strong communication and teamwork abilities
• Proficiency with electronic data capture systems

Education

• Relevant degree or certification as described in Qualifications

Additional Requirements

• Frequent, and at times international, travel required
• Ability to work in a fast-paced, changing environment with stringent timelines
• Willingness to work in an environment heavily reliant on electronic data capture