Remote United States
52 days ago
Clinical Trial Associate

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

 

Position Summary:

In this role you will execute and coordinate activities associated with the set-up, management, and close-out of clinical trials. Collaborate with other functional areas to facilitate administrative tasks including invoices and contracts for processing. Assist in oversight of outsourced activities.

Responsibilities:

The scope of study responsibilities includes supporting the effective coordination of the activities of the clinical trial, management of project information and communications to all stakeholders through the lifecycle of drug development. Assist the Clinical Project Manager in management, execution, and oversight of assigned studies/tasks incl. Coordinate the development and review of study documents (i.e., posting study specific training documents in MC, IB, Protocol, ICF, plans, manuals, site recruitment materials, CSRs, etc.) Assists with vendor selection and management activities, incl. management of applicable documentation and systems. Functional contact for CROs and vendors. Documents meetings as assigned. Assists with the development and maintenance of study timeline and processing of budget/invoice/contracts and other trackers Ensure study training is documented for all study team members Document study specific decisions, actions, issues, and risks throughout the lifecycle of the study Maintain data in assigned systems Assist on inspection readiness activities

Qualification Requirements:

Bachelor’s degree in health profession or science field A minimum of 3 years of experience in the medical device or pharmaceutical industry, including 1 years of relevant clinical research experience Some monitoring experience is preferred Excellent written and oral communication skills Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc. Excellent organizational skills and attention to detail Ability to work virtually Ability to apply knowledge of GCP and applicable regulations and guidance’s appropriately Office or remote based. Some travel may be required for educational seminars, on-site study oversight and site engagement visits. Ability to travel approximately 5%.

 

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/.

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