Clinical Trial Assistant

Company Description

Opus Genetics is a clinical-stage biopharmaceutical company dedicated to developing innovative gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The company’s pipeline includes AAV-based gene therapies for conditions like Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Lead candidates include OPGx-LCA5, currently in a Phase 1/2 trial, and OPGx-BEST1 targeting BEST1-related retinal degeneration. In addition, Opus Genetics is advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy studied in Phase 3 trials for visual conditions such as presbyopia and nighttime vision disturbances. Opus Genetics is headquartered in Durham, NC, and is committed to advancing groundbreaking treatments to support individuals with serious ophthalmic disorders.

Job Title: Clinical Trial Assistant, Clinical Operations                      Department: Clinical Development

Reports to: Sr. Director Clinical Operations  

Position Summary:

The Clinical Trial Assistant provides essential administrative and operational support to the Clinical Operations team across all phases of clinical trials (Phase I–III focus). In a small biotech environment, this role offers broad exposure to clinical development processes and the opportunity to contribute meaningfully to study execution while learning from experienced clinical professionals. The ideal candidate is highly organized, detail-oriented, proactive, and thrives in a fast-paced, resource-conscious setting.

Key Responsibilities

·      Provide Sponsor oversight of the electronic Trial Master File (eTMF) for assigned studies to ensure inspection-readiness and compliance with ICH-GCP, FDA regulations, and company SOPs

·      Assist with collection, review, filing, and archiving of essential study documents from clinical sites, vendors/CROs, and internal teams as necessary

·      Support study start-up activities, including preparation of clinical study documents

·      Coordinate and track submission of documents to IRBs/ECs and central IRBs; monitor approval status and follow up on outstanding items

·      Manage clinical trial supplies: track inventory, coordinate ordering/shipment of investigational product (IP), lab kits, and ancillary supplies with vendors and sites

·      Schedule and organize internal and external meetings (investigator meetings, CRO/vendor calls, study team meetings); prepare agendas, take minutes, and distribute follow-up actions as necessary

·      Serve as a central point of contact for routine site communications; distribute protocol amendments, safety updates, and other study correspondence

·      Assist in tracking study milestones, enrollment progress, site activation status, and key performance metrics

·      Support vendor/CRO management activities, including setup of contracts, change orders, invoices, and performance tracking

·      Provide support with contract preparation and execution (manually or via a software system) for the administrative and clinical development teams.

·      Provide Sponsor oversite of sponsor study-level training documentation

·      Route clinical study documents for review and approval, as well as electronic signature tracking and filing of final documents.

·      Help prepare materials for internal reviews, DSMB/IDMC meetings, and regulatory interactions

·      Participate in quality control reviews of study documents and data listings as needed

·      Contribute to process improvements and SOP development within the small clinical team

Qualifications Required:

·      Bachelor’s degree in life sciences, biology, health sciences, nursing, or related field (or equivalent combination of education and experience)

·      2-5 years of experience in clinical research support, preferably in a biotech setting. CRO or Pharmaceutical will be considered

·      Knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes

·      Meticulous attention to detail. Excellent organizational and time-management skills

·      Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat

·      Ability to work independently and collaboratively in a small-team environment with limited resources

·      Strong written and verbal communication skills

What We Offer

·      Opportunity to grow within a rapidly advancing clinical-stage biotech

·      Exposure to end-to-end clinical development in a small, high-impact team

·      Competitive salary and equity package commensurate with experience

·      Comprehensive benefits including health, dental, vision, 401(k), and paid time off

·      Position is currently remote or hybrid for those near our office in the Raleigh/Durham area. East Coast candidates preferred.

Physical Requirements:

·      Prolonged periods of sitting at a desk and working on a computer.

·      Must be able to lift up to 15 pounds at times.

Location: This is a remote position, though candidates residing within commuting distance to our Raleigh North Carolina office will receive priority consideration for occasional, in-person team engagement.

Salary Range:

$85,000-100,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.