Senior Clinical Research Associate II – Ophthalmology

This is a fully remote position, open to applicants in Connecticut, +9 more states.

📋 Description

• Deliver exceptional care to participants involved in clinical trials and respond effectively to emergency situations according to clinical research standards.

• Oversee all components of study site monitoring, including regular monitoring and the closure of clinical sites.

• Maintain comprehensive study files and carry out pre-study and initiation visits.

• Collaborate with vendors to ensure project success.

• Manage study sites in alignment with project plans.

• Ensure that study staff receive the necessary materials and instructions to safely enroll patients.

• Verify that informed consent procedures and protocol requirements adhere to relevant regulations.

• Safeguard the integrity of data submitted on Case Report Forms and other data collection instruments.

• Monitor data for any missing or implausible entries.

• Manage registries and perform feasibility assessments as needed.

• Complete reporting on Serious Adverse Events, including reports, narratives, and follow-up actions.

• Conduct CRF reviews and generate and resolve queries within Fortrea or client data management systems.

• Support the training of new employees through co-monitoring activities.

• Coordinate specified clinical projects in the role of Local Project Coordinator.

• Serve as a local client contact when designated.

• Execute additional tasks as assigned by management.

⛳️ Requirements

• Must reside on the East Coast of the US.

• Possess a university or college degree, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure).

• Have over 5 years of Clinical Monitoring experience.

• Oncology experience is preferred, particularly in early-phase studies.

• Willingness to travel overnight 30-50% of the time.

• Capability to thrive in a fast-paced, technology-driven environment with shifting priorities.

• Strong teamwork and interpersonal skills.

• Ability to sit for prolonged periods and operate a vehicle safely.

• Repetitive hand movements and the ability to perform quick, simple, repeated actions with fingers, hands, and wrists.

• Occasional crouching, stooping, and frequent bending and twisting of the upper body and neck.

• Proficient in accessing and utilizing various computer software.

• Capable of light to moderate lifting and carrying of items, including luggage and a laptop computer, weighing up to 15-20 lbs.

• Consistent and regular attendance is required.

• Flexible hours may be necessary.

🏝️ Benefits

• Flexible remote work arrangement.

• Continuous acceptance of applications.