Senior Clinical Research Associate II – Ophthalmology

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

📋 Description

• Execute all facets of study site monitoring, which includes routine oversight and closure of clinical sites.

• Maintain comprehensive study files and conduct pre-study and initiation visits.

• Serve as a liaison with vendors.

• Oversee study sites in alignment with project plans.

• Ensure that study personnel receive the necessary materials and guidance for the safe enrollment of patients.

• Verify compliance of informed consent procedures and protocol requirements with relevant regulations.

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

• Monitor source data for any missing or implausible information.

• Manage registries according to project plans and perform feasibility assessments as needed.

• Complete Serious Adverse Event reporting, including the drafting of reports, narratives, and follow-ups.

• Independently conduct CRF reviews and generate/resolve queries utilizing Fortrea or client data management systems.

• Assist in training new team members through co-monitoring activities.

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

• Act as a local client liaison when designated.

• Carry out other responsibilities assigned by management.

⛳️ Requirements

• Bachelor’s degree or certification in a related allied health field from an appropriately accredited institution (e.g. nursing licensure).

• A minimum of 5 years of experience in Clinical Monitoring.

• Experience in oncology; early phase experience is preferred.

• Willingness to undertake 30-50% overnight travel.

• Ability to thrive in a fast-paced, deadline-oriented, protocol-compliant environment.

• Capacity to prioritize tasks and adapt to shifting priorities.

• Strong teamwork and interpersonal skills.

• Comfortable working within a technology-driven electronic data landscape.

• Ability to sit for extended durations and operate a vehicle safely.

• Repetitive hand movements with both hands, demonstrating the ability to execute quick, simple, repeated motions of the fingers, hands, and wrists.

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

• Proficient in accessing and utilizing various in-house and off-the-shelf computer software.

• Capability to lift and carry weights of 15-20 lbs.

• Regular and consistent attendance is required.

• Varied hours may be necessary.

🏝️ Benefits

• 30-50% overnight travel.

• Continuous acceptance of applications.