FSP - Sr. CRAs & CRA 1/2 - Ophthalmology

Our FSP team is seeking experienced CRAs with Ophthalmology monitoring experience. Major hub locations around the US will be considered. Regional travel with occasional outside travel at times. Oncology and cardiology experience is also a plus. We are hiring at the Sr. CRA level and CRA 1s and 2s (1-2 years of monitoring).

Responsibilities

• 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.
• Handle 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 perform other duties as assigned.
• Manage all aspects of site management as prescribed in the project plans.
• Perform general on-site monitoring.
• Ensure study staff have received 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 applicable regulatory requirements.
• Ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
• Monitor data for missing or implausible data.
• Handle 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.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• 4+ years of Clinical Monitoring experience for Sr. CRAs.
• Ophthalmology experience is required.
• 60-70% overnight travel.
• Comfortable working in a fast-paced environment where no deviations from the study protocol are allowed, and timelines must be strictly met.
• Ability to adapt to constantly changing priorities and reprioritize on the spot.
• Strong teamwork and people skills essential for smooth study operations.
• Comfort with technology-based data collection directly into an electronic environment.

Work Environment

Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/site locations with occasional domestic and international travel.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Pay

Target pay range: $110,000 - $145,000 based on title.