Job Description
About the Role
Ensuring the most effective and efficient conduct of clinical research studies by providing administration, regulatory and project tracking support. The CTA will accept projects as assigned per the changing needs of the Clinical Operations Department. Experience with Trial Master File (TMF) maintenance is required.
Let’s talk about some of the key responsibilities of the role:
- Organize and maintain clinical study documentation (e.g., Trial Master Study Files) including preparation for internal/external audits, final reconciliation and archival.
- Responsible for the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist Clinical Research Associates (CRAs) and the clinical teams with accurately updating and filing clinical documents from study visits and updating systems that track site compliance and performance within project timelines.
- Completes periodic review of study files for completeness and audit readiness.
- Assist Study Manager with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of study trial data, queries, and clinical data flow.
- Provide general administrative support to the Clinical Operations Department and Study Manager(s) as needed.
- Co-ordinate ordering/dispatch and tracking of trial materials (e.g. source, diary cards, lab supplies, drug supplies) as appropriate.
- Contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).
- Assist in the tracking and distribution of safety reports.
- Co-ordinate document translation, if required.
- Attend clinical team meetings and generate meeting minutes.
- Assist in the production of PowerPoint slides, including graphics, as needed for project, departmental, sponsor and/or business development presentations.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
Factors for Success:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree, or an Associate degree with minimum of 2 years, working with study related regulatory files.
- Experience working with and maintaining, an electronic Trial Master File.
- Must be familiar with ICH/GCP guidelines and appropriate regulatory regulations.
- Strong organizational skills with the ability to manage multiple tasks with meticulous attention to detail.
- Excellent written and verbal communication skills.
- Computer literacy: e.g., Microsoft Word, Excel, PowerPoint, Outlook.
- Knowledge of clinical trials software (eDC systems).
- The ability to prioritize workload with minimal supervision.
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 Trials.
- Some travel may be required – up to 10%
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $69,000 - $96,600 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
Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
