Clinical Trial Associate

Ocugen • Malvern, PA

353d

About The Position

The Clinical Trial Associate supports the operational execution of clinical studies. This individual will be responsible for the successful delivery of clinical studies including conducting LDNA tests for clinical studies according to agreed cost and timelines while ensuring patient safety and data integrity and quality.

Requirements

• BA/BS degree, preferably in life sciences.
• 1+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry.
• Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality and on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

Nice To Haves

• Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 is a plus.
• Experience with eTMF, CTMS and EDC is a plus.

Responsibilities

• Review and complete training on all applicable SOPs, and Manual of Procedures required for conducting LDNA testing in adherence to study protocol, ICH/GCP guidelines and government regulations.
• Work collaboratively with clinical sites to schedule LDNA tests for study participants in adherence to study protocol.
• Work collaboratively with the Clinical Research Associate to set up the appropriate Course/ Maze assessment layout selected for the LDNA test.
• Provide verbal instructions on LDNA testing procedures to study participants only during a practice walk-through (i.e. prior to the actual test being done).
• Ensure equipment used for LDNA testing such as table, laptop, & camera are set up appropriately prior to each LDNA test for study participants.
• Ensure all LDNA tests completed are video-recorded and transmitted appropriately and timely to the LDNA administrator for review.
• Additional tasks and projects as requested.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees