Clinical Trial Associate - CEDENT

We are looking for a Clinical Trial Associate to support the operational execution of clinical studies, including conducting LDNA tests. This role ensures successful study delivery by adhering to agreed timelines, maintaining patient safety, and ensuring data quality and integrity. The Clinical Trial Associate will collaborate with clinical sites and internal teams to manage LDNA testing while following regulatory and protocol guidelines.
 

• Review and complete training on applicable SOPs and Manuals of Procedures required for LDNA testing in compliance with study protocols, ICH/GCP guidelines, and regulatory requirements.

• Collaborate with clinical sites to schedule LDNA tests for study participants as per protocol requirements.

• Work with Clinical Research Associates to set up the appropriate Course/Maze assessment layout for LDNA tests.

• Provide verbal instructions on LDNA testing procedures to study participants during practice walkthroughs prior to actual testing.

• Ensure proper setup of equipment used for LDNA testing, including tables, laptops, and cameras, before each test.

• Ensure all LDNA tests are video-recorded and transmitted in a timely manner to the LDNA administrator for review.

• Complete additional tasks and projects as assigned.
   

• Bachelor’s degree, preferably in life sciences.

• 1+ years of progressive clinical research experience in the biotechnology or pharmaceutical industry.

• Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 is a plus.

• Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.

• Demonstrated attention to detail and outstanding organizational skills.

• Self-motivated with a commitment to high-quality and on-time deliverables.

• Excellent communication and collaboration skills with a team-oriented approach.

• Familiarity with eTMF, CTMS, and EDC systems is a plus.

• Proven ability to identify and resolve issues effectively while managing timelines.

• Work location: This position operates in an office setting with up to 20% travel to visit sites. Flexibility outside standard hours may be required to address priority business needs.
   

• Primarily a sedentary role but may require standing, bending, kneeling, and lifting weights up to 10 lbs.