Tarsus Pharmaceuticals, Inc. · 1 month ago
Sr Clinical Research Associate (CRA)
United States
Full-time
Remote
Senior Level
$110K/yr - $153K/yr
5+ years expTarsus Pharmaceuticals, Inc. is seeking a Senior Clinical Research Associate (CRA) to act as a customer advocate through the study life cycle. The role involves organizing clinical study documentation, monitoring study sites, and ensuring compliance with regulatory requirements while supporting clinical planning and execution.
PharmaceuticalBiotechnologyLife ScienceBiopharma
Responsibilities
As an investigator site facing role, the Sr. CRA will act as a customer advocate through a study life cycle
Understand and support study goals in alignment with corporate goals
Organize and maintain clinical study documentation (e.g., Trial Master Study Files) including preparation for internal/external audits, final reconciliation and archival
Where appropriate, responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits and appropriate documentation (confirmation, follow-up letters, communication logs, as required)
When monitoring has been delegated to a CRO, provides Sponsor oversight of monitoring activities
Assists in the development of study specific monitoring procedures and guidelines
Involved in the development or review of protocols, Case Report Forms (CRFs), informed consent forms and any other study-related documents as assigned
Assists in managing the identification, selection and feasibility processes of study sites
Ensures the study sites have received the proper materials and instructions to safely enter patients into the study; helps to train the study staff in conducting the study per GCP and in performing procedures per protocol
Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Where appropriate, ensures the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitors for missing or implausible data
Prepares accurate and timely trip reports or site audit reports in accordance with Good Clinical Practice Guidance E6(R3) and internal SOPs
Interacts with internal groups to evaluate needs, resources and timelines
Acts as a contact for clinical trial supplies and other suppliers (vendors) as assigned
Supports the revision and implementation of Clinical Affairs SOPs/procedures
Supports inspection readiness for the company, to ensure its contractors and vendors are prepared for FDA and other Health Authority GCP inspections
Supports oversight of Trial Master Files
Provides support to Clinical Development and Operations for clinical planning, start-up, execution and close-out
Qualification
Required
Bachelor's degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology preferred
Minimum of five (5) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring, close-out visits) at an eye care Pharmaceutical, Biotech or CRO company
Pharmaceutical and ophthalmology experience required
Thorough knowledge of ICH/GCP R3 Guidelines
The ability to thrive with minimal supervision
The drive to resolve project-related problems and can prioritize workload for self and team
Mentoring of other CRAs on monitoring, internal procedures and query resolution
Excellent knowledge of MS Office, Excel, PowerPoint as well as data management and clinical trials software
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there's not a blueprint for success. Owns their decisions and actions
Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first
Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met
Preferred
Vendor oversight experience preferred
Benefits
Bonus
Stock equity
Comprehensive benefits
Health, dental and vision insurance benefits to ensure your well-being
Generous paid time off, including vacation, holidays, and personal days
Hybrid work environment
This position can also be remote
Onsite gym, pool, snacks, drinks, and occasional catered meals
Company
Tarsus Pharmaceuticals, Inc.
Tarsus (NASDAQ:TARS) is a biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$710.6MKey Investors
Pharmakon AdvisorsVivo Capital
2025-03-12Post Ipo Equity· $125M
2024-04-19Post Ipo Debt· $75M
2024-02-29Post Ipo Equity· $100M
Leadership Team
Bobak Azamian
Chairman
Elizabeth Yeu
Chief Medical Officer
Recent News
Orange County Business Journal
2026-07-16
Orange County Business Journal
2026-07-12
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