Sr Clinical Research Associate (CRA)

Tarsus Pharmaceuticals•Irvine, CA

1d•$109,500 - $153,300•Hybrid

About The Position

As an investigator site facing role, the Sr. CRA will act as a customer advocate through a study life cycle. This role involves understanding and supporting study goals in alignment with corporate goals. The Sr. CRA will be responsible for organizing and maintaining clinical study documentation, including preparation for audits, final reconciliation, and archival. They will also be responsible for all aspects of study site monitoring, including routine monitoring and close-out, maintenance of study files, and conducting pre-study and initiation visits. When monitoring is delegated to a CRO, the Sr. CRA provides Sponsor oversight of monitoring activities. This role assists in the development of study-specific monitoring procedures and guidelines, and is involved in the development or review of protocols, Case Report Forms (CRFs), informed consent forms, and other study-related documents. The Sr. CRA assists in managing the identification, selection, and feasibility processes of study sites, ensuring sites have the proper materials and instructions to safely enroll patients and training study staff. They ensure the protection of study patients by verifying adherence to informed consent procedures and protocol requirements, and ensure the integrity of data submitted on CRFs through source document review. The Sr. CRA prepares accurate and timely trip reports or site audit reports, interacts with internal groups to evaluate needs, resources, and timelines, and acts as a contact for clinical trial supplies and other vendors. They support the revision and implementation of Clinical Affairs SOPs/procedures, support inspection readiness for the company, and provide support to Clinical Development and Operations for clinical planning, start-up, execution, and close-out.

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 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.

Nice To Haves

Vendor oversight experience preferred.

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.
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(R3) 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.