Clinical Trial Associate

Department:

106600 Clinical Operations

Location:

San Diego

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 patients. Our 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 in this position must be performed in accordance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Travere’s 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.

• Ensure 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 appropriate 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 start‐up 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 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.

• 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: 

• Bachelor’s 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 Travere’s 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 Microsoft Suite required.

• Knowledge of Smartsheet, MS Project, Visio, and/or Veeva is a plus.

   

   

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

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:

$74,000.00 - $96,000.00

*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 candidate’s 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 accommodations@travere.com. 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.