Clinical Trial Associate

Department:

Location:

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare work is rewarding both professionally and personally because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative diverse fast-paced environment and share in our mission to identify develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients courage community and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:
The Clinical Trial Associate (CTA) will be responsible for assisting the project team in running the day-to-day operational activities of clinical studies. Under the guidance of Clinical Operations management the individual will coordinate track and manage daily activities for multiple clinical studies to support the internal project team vendors stakeholders and CROs as applicable.
All activities required of this position must be performed in accordance with Good Clinical Practice (GCP) International Council for Harmonisation (ICH) and Traveres Standard Operating Procedures (SOP).

Responsibilities:

Familiar with FDA regulations as well as GCP/ICH requirements.
Assists the study team in all aspects of the day-to-day operational activities of clinical studies. Coordinates tracks and manages daily activities for multiple clinical studies to support the internal project team vendors stakeholders and CROs as applicable.
Coordinates project meetings including scheduling preparation of meeting materials drafting and distribution of meeting agendas and minutes.
Ensures that delegated components of clinical trials are executed in accordance with specified SOP and within defined timelines.
Under the guidance and direction of Clinical Operations team the CTA interfaces with other Travere R&D functions to coordinate relevant and timely exchange of information materials and/or reviews to support successful trial operations and management consistent with the drug development plan.
Works directly with Clinical Operations and study team to optimize and implement clinical studies according to GCPs and relevant SOPs.
Receive review and assess study documents required for site activation and investigational product release.
Maintain metrics on results of study documentation reviews and patient enrollment.
Create and ship investigator site binders as applicable.
Assist with IRB submissions and IRB correspondence. Ensure all documents are added to the electronic Trial Master File (eTMF) with appropriated naming conventions per relevant SOPs.
Supports internal Clinical Operations in monitoring the implementation and progress of a clinical study.
Manage and update study contact lists.
Supports reconciliation of vendor invoices/PO management as well as vendor and contractor payments as applicable.
Tracks study status enrollment EDP review and site startup status for assigned clinical projects including review and approval of regulatory package for release of investigational product.
Responsible for setup maintenance reconciliation transfer (if applicable) and archiving of the eTMF along with internal working files.
Assists with eTMF oversight reviews to ensure quality accuracy and completeness.
Interacts with CROs vendors investigators monitors and other external partners to provide information and resolution for specific study requests and issues.
Responsible for document management within digital systems.
Supports the development maintenance and implementation of SOPs and Working Instructions.
Actively participates in the development of department initiatives; contributes ideas on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.
Identify gaps in operational processes to ensure compliance in applicable SOPs in the achievement of study milestones data quality and data integrity.

Education/Experience Requirements:

Bachelors degree or equivalent in a biomedical life science or related field of study. Equivalent combination of education and applicable job experience may be considered.
Minimum 1-2 years of related experience; clinical operations experience in a pharmaceutical or CRO setting preferred.

Additional Skills/Experience:

The ideal candidate will embody Traveres core values: Courage Community Spirit Patient Focus and Teamwork.
Familiar with FDA regulations GCPs and ICH guidelines is required.
Proactive self-starter who possesses strong multi-tasking and communication skills both oral and written.
Good problem-solving skills and a strong sense of urgency keen attention to detail ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
Intermediate proficiency in the Microsoft Suite required.
Knowledge of Smartsheet MS Project Visio and/or Veeva is a plus.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse equitable people-centric and pay-for-performance organization.

Benefits: Our benefits include premium health financial work-life and well-being offerings for eligible employees and dependents wellness and employee support programs life insurance disability retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock) designed to recognize retain and reward employees.

Target Base Pay Range:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidates experience education skills and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process please contact us by sending an email to . Please note that this email address is to be used exclusively to request an accommodation with the online application interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.