Job Description

As part of a clinical study team, the in-house Clinical Research Associate (CRA) study team, plays a key role in supporting the execution of clinical trials. The in-house CRA collaborates with the Clinical Study Manager and other cross-functional team members to aid in the overall study execution, including tracking key study metrics.

Essential Duties & Responsibilities:

• Develop and maintain metrics through clinical study completion to support the Clinical Study Manager to ensure study is executed per protocol, within timelines and in compliance with regulatory requirements.
• Draft and review study documents such as informed consents, source documents, and meeting materials.
• Participate in study team meetings and contribute to study progress updates.
• Assist with training of site study team regarding the monitoring plan, recording & maintenance of essential documents, and startup and site initiation activities under the guidance of the Study Manager.
• Responsible for contributing and making submissions to the Central IRB/ethical committees as applicable
• Track and monitor day to day study related activities such as patient enrolment, data entry, and regulatory document review.
• Review of monitoring reports and identify potential trends and issues that may need escalation to the management team.
• Collaborate with data management teams during the data review process to ensure timely resolution of data-related issues. Reach out to Regional Monitors and sites for complex or outstanding queries and identify query resolution issues.
• Assist in the preparation and presentation of study materials at Investigator, Study Coordinator and ad-hoc meetings.

Education And/Or Experience:

• 5+ years relevant clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required with at least some experience as an in-house clinical trial associate. Years of experience and degree of prior responsibilities will determine title/level
• University degree equivalent to bachelor’s degree preferably in a scientific discipline
• Experience working in ophthalmology clinical trials is strongly preferred.

Supervisory Responsibilities: No

Other Skills & Abilities:

• Good computer skills: Word, Excel, PowerPoint, Outlook. Experience with electronic data capture systems a plus.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills: ability to interface with other functions within the company.
• Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve.
• Thorough understanding of ICH-GCP guidelines and FDA regulations.