LDNA Coordinator

at  Ocugen Opco Inc

WORKING CONDITIONS

• This position operates in an office setting and may include 80% of travel to visit sites. This Job may require incumbent to be available outside of these hours to handle priority business needs.

PHYSICAL REQUIREMENTS

• Involved preparing site for participation.
• Ability to climb step stool or ladders to replace light bulbs.
• Requires daily check of lighting systems based very low to the ground.
  Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individuals conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,
  current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment

JOB PURPOSE

The LDNA Coordinator plays a supporting role in the operational execution of clinical studies, specifically focusing on coordinating LDNA tests for clinical studies. This individual will assist in the successful delivery of these studies by ensuring the proper scheduling and setup of LDNA tests, while maintaining patient safety, data quality, and adherence to timelines. The role requires frequent domestic travel to clinical sites.

DUTIES AND RESPONSIBILITIES

• Complete required training on all applicable SOPs and the Manual of Procedures related to LDNA testing in accordance with study protocols, ICH/GCP guidelines, and government regulations.
• Coordinate with clinical sites to schedule LDNA tests for study participants, ensuring adherence to the study protocol.
• Assist the LDNA Administrator in setting up the Course/Maze assessment layout for the LDNA tests and LDNA administration.
• Provide verbal instructions on LDNA testing procedures to study participants during a practice walk-through prior to the actual test.
• Ensure that equipment such as LDNA course, tables, laptops, and cameras are appropriately set up and the course calibrated for each LDNA test.
• Ensure that all LDNA tests are video-recorded and transmitted in a timely manner to the LDNA Administrator for review.
• Ensure proper documentation is maintained as per study protocol procedures to conduct LDNA testing.
• Generates the LDNA final assessment form in collaboration with Study Leads.
• Perform additional tasks and assist with projects as needed.
• BA/BS degree, preferably in life sciences.
• 1+ years of experience in clinical research or a related field, preferably in biotechnology or pharmaceuticals.
• Experience in ophthalmology or advanced therapy studies in Phases 1-3 is a plus.
• Basic knowledge of GCP, ICH, and FDA regulations governing clinical studies.
• Strong attention to detail and excellent organizational skills.
• Self-motivated, with the ability to manage tasks efficiently and meet deadlines.
• Strong communication and teamwork skills.
• Familiarity with eTMF, CTMS, and EDC systems is a plus.
• Ability to troubleshoot issues and assist in maintaining timelines.