Clinical Research Associate II jobs in United States
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Tarsus Pharmaceuticals, Inc. · 17 hours ago

Clinical Research Associate II

Tarsus Pharmaceuticals, Inc. is a company focused on advancing clinical trials in the pharmaceutical space. The Clinical Research Associate II will be responsible for executing clinical trials, resolving study site issues, and engaging with various stakeholders to ensure the successful completion of clinical studies.

BiopharmaBiotechnologyLife Science

Responsibilities

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

Qualification

Clinical research experienceTrial Master File managementICH/GCP R2 GuidelinesSite monitoring skillsMS Office proficiencyAttention to detailProblem-solvingFlexibilityTeamwork

Required

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
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

Preferred

Pharmaceutical experience preferred

Benefits

Health, dental and vision insurance benefits to ensure your well-being
Generous paid time off, including vacation, holidays, and personal days

Company

Tarsus Pharmaceuticals, Inc.

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Tarsus (NASDAQ:TARS) is a biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care.

Funding

Current Stage
Public Company
Total Funding
$710.6M
Key Investors
Pharmakon AdvisorsVivo Capital
2025-03-12Post Ipo Equity· $125M
2024-04-19Post Ipo Debt· $75M
2024-02-29Post Ipo Equity· $100M

Leadership Team

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Jeffrey Farrow
Chief Financial Officer and Chief Strategy Officer
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Bobak Azamian
Chairman
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Company data provided by crunchbase