Clinical Trial Ldna Administrator

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Job description

Job Purpose

The LDNA Administrator 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. This job requires frequent domestic travel to our sites.

Duties and 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 and communicate LDNA test result to the sites.
• Work collaboratively with the LDNA coordinator 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).
• Ensures equipment used for LDNA testing such as table, laptop, & camera are set up appropriately prior to each LDNA test for study participants.
• Ensures all LDNA tests completed are video-recorded and transmitted appropriately and timely to the LDNA assessors for review.
• Generates the LDNA final assessment form in collaboration with Study Leads and communicates the results to the clinical sites.
• Additional tasks and projects as requested.

Qualifications

• BA/BS degree, preferably in life sciences.
• 2+ years of progressive clinical research experience in the biotechnology/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.
• Previous experience with patient interaction in clinical or research projects is a plus.
• 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.
• Experience with eTMF, CTMS and EDC is a plus.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

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 in 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 individual's 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.

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