Sr Clinical Research Associate (CRA)

Tarsus Pharmaceuticals•Irvine, CA

11h•Hybrid

About The Position

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.

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.
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.
Mentoring of other CRAs on monitoring, internal procedures and query resolution.

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 study sites have received the proper materials and instructions to safely enter patients into the study.
Train 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.