Clinical Research Associate II

About the Role

Responsible for the successful execution of clinical trials, this role will proactively resolve study site issues and participate in process improvement initiatives as applicable. The CRA engages with study investigators, vendors, and internal/external stakeholders as a member of the Clinical Trial Development and Operations team. This role will accept projects as assigned per the changing needs of the Clinical Development Department.

Let’s talk about some of the key responsibilities of the role:

• 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).
• Reviews study specific monitoring procedures and guidelines.
• Involved in the development or review of protocols, Case Report Forms (CRFs), investigator brochures, 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 staff who will conduct the protocol 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 R2. 
• Organizes and makes presentations at Investigator Meetings.
• Acts as a contact for clinical trial supplies and other suppliers (vendors) as assigned.
• Reviews and assists in the preparation of Clinical Study Reports (CSRs).
• Provides support to Clinical Development and Operations for clinical planning, start-up, execution and close-out.

Factors for Success:

• University/college 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 2 years of clinical research experience (including pre-study, initiation, routine monitoring and close-out visits) at a Pharmaceutical, Biotech or CRO company.
• Minimum of two (2) years of experience with Trial Master File (TMF) management/maintenance.
• Pharmaceutical experience preferred.
• Thorough knowledge of ICH/GCP R2 Guidelines.
• Site monitoring skills.
• The ability to thrive with minimal supervision.
• The drive to resolve project-related problems and can prioritize workload for self.
• Flexibility to adjust to changing needs in the Clinical Development Department and organization.
• Excellent knowledge of MS Office, Excel, PowerPoint as well as project management and clinical trials software (eDC systems).
• Ability to manage competing priorities in a fast-paced environment.
• Strict attention to detail.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. [Remote work is an option.]
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Manager II, Clinical Research.
• Some travel may be required – up to 60%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $86,200 - $120,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

#LI-Remote