Senior Associate, Clinical Research

Summary

Join Tarsus Pharmaceuticals as a Senior Clinical Research Associate (Sr. CRA) and act as a customer advocate throughout the study lifecycle. You will be responsible for various aspects of clinical study monitoring, including site visits, documentation, and data integrity. This role requires a Bachelor's degree (life science preferred) or related certification, along with at least five years of clinical research monitoring experience in ophthalmology. The position offers a hybrid work environment (Irvine office or remote), travel up to 60%, and a competitive salary ($105,000-$147,000) plus bonus, stock equity, and comprehensive benefits including health, dental, vision, and generous paid time off. You will work closely with internal teams and external vendors, contributing to study planning, execution, and close-out. Mentoring other CRAs is also a key aspect of this role.

Requirements

• 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 R2 Guidelines
• 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

Responsibilities

• 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
• 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)
• Provide Sponsor oversight of monitoring activities when monitoring has been delegated to a CRO
• Assist 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
• Assist in managing the identification, selection and feasibility processes of study sites
• Ensure the study sites have received the proper materials and instructions to safely enter patients into the study; help to train the study staff in conducting the study per GCP and in performing procedures per protocol
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure 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
• Prepare accurate and timely trip reports or site audit reports in accordance with Good Clinical Practice Guidance E6 R2 and internal SOPs
• Interact with internal groups to evaluate needs, resources and timelines
• Act as a contact for clinical trial supplies and other suppliers (vendors) as assigned
• Support the revision and implementation of Clinical Affairs SOPs/procedures
• Support inspection readiness for the company, to ensure its contractors and vendors are prepared for FDA and other Health Authority GCP inspections
• Support oversight of Trial Master Files
• Provide support to Clinical Development and Operations for clinical planning, start-up, execution and close-out
• Mentoring of other CRAs on monitoring, internal procedures and query resolution

Preferred Qualifications

• Vendor oversight experience preferred
• The ability to thrive with minimal supervision
• The drive to resolve project-related problems and can prioritize workload for self and team

Benefits

• Hybrid work environment
• Remote work option
• Health, dental and vision insurance benefits
• Generous paid time off, including vacation, holidays, and personal days
• Bonus
• Stock equity