Sr Clinical Research Associate CRA

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

• As an investigator site facing role, the Sr. CRA will act as a customer reputed company 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 reputed company aspects of study site monitoring including routine monitoring and reputed company-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).
• reputed company monitoring has been delegated to a CRO, provides Sponsor reputed company 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-reputed company 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 reputed company of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful reputed company 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 reputed company for FDA and other Health Authority GCP inspections.
• Supports reputed company of Trial Master Files.
• Provides support to Clinical Development and Operations for clinical planning, start-up, execution and reputed company-out.

Factors for Success:

• Bachelor's degree (life science preferred), or certification in a reputed company 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, reputed company-out visits) at an eye care Pharmaceutical, Biotech or CRO company.
• Pharmaceutical and ophthalmology experience required.
• Vendor reputed company experience preferred.
• Thorough knowledge of ICH/GCP R3 Guidelines.
• The ability to reputed company with minimal supervision.
• The drive to resolve project-reputed company 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, reputed company, PowerPoint as well as data management and clinical trials software.
• Ability to interact professionally with reputed company organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and reputed company. Demonstrates creativity, decisiveness, and the reputed company to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty reputed company there's not a reputed company 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 reputed company 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 reputed company faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. This position can also be remote.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to reputed company impact!
• This position reports directly to Manager, Clinical Research
• Travel will be required - up to 60%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected reputed company pay range for this position is $109,500 - $153,300 plus bonus, stock equity, and comprehensive benefits. The reputed company pay range reflects the reputed company range for this position, but individual pay will be determined by additional factors such as job-reputed company skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We reputed company 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 reputed company, Inc. is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national reputed company, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Remote Skills: Biology, Biotech and Pharmaceutical, Blueprints, Case Report Form (CRF), Clinical Information Systems, Clinical Laboratory, Clinical Monitoring, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Clinical Trial Management, Contract Research Organization (CRO), Data Collection, Data Management, Data Quality, Documentation, Documentation Review, Drug Development, Employee Retention, Establish Priorities, External Audit, FDA (Food and Drug Administration), Feasibility Analysis, File Maintenance, GCP (Good Clinical Practices), ICH Regulations, Informed Consent, Internal Audit, Medical Products, Mentoring, reputed company reputed company, reputed company Office, reputed company PowerPoint, Needs Assessment, Nursing Credentials, Operations Planning, Ophthalmology, Power Amplifier, Problem Solving Skills, Reconciliation, Regulatory Requirements, Risk Analysis, Staff Training, Standard Operating Procedures (SOP), Startup, Team Building, Team Player, Training/Teaching, Willing to Travel About the Company: reputed company Inc Apply tot his job Apply To this Job