Clinical Operations Associate

At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position Summary

We are seeking a highly motivated individual to join the Retrophin team as a Clinical Operations Associate (COA) who can both prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment. The COA will be responsible for assisting the study 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 the CROs.

Essential Functions

• Demonstrate a clear understanding of FDA regulations, ICH Guidelines and Good Clinical Practice (GCP).
• Assists the study team in running 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 the CROs as applicable.
• Serve as a liaison and resource for investigational sites.
• Ensures that delegated components of clinical trials are executed to expected and specified quality standards and timelines.
• Under the guidance and direction of Clinical Operations team, interfaces with other Retrophin R&D functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process.
• 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.
• Create and maintain site binders to investigator sites including specific document templates, scanning and routing for filing in the TMF.
• Assist with IRB submissions and IRB correspondence. Ensure all documents are added to the TMF with appropriated naming conventions.
• Supports internal Clinical Operations in monitoring the implementation and progress of a clinical study.
• Develops and maintains relationships with external vendors.
• Ensure the study team contacts list, vendor contact list, site contact list is current.
• Collaborates with consultants and contractors as directed by the Clinical Operation study team member.
• Working closely with Clinical Operations in coordinating, tracking, and the management of logistics in support of clinical trials.
• Responsible for reconciliation of vendor invoices/PO management, as well as, vendor and contractor payments.
• Tracks study status, enrollment, regulatory documentation, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
• Responsible for set‐up, maintenance, reconciliation, and archiving of Trial Master Files (TMF) along with internal working files, and coordinates TMF transfer with CROs.
• Assists with TMF oversight review as required for 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 in electronic database systems and investigator database.
• Coordinates project meetings, including scheduling, preparation of meeting materials, drafting and distribution of meeting agendas and minutes.
• Supports the development and implementation of Standard Operating Procedures (SOPs) and common work practices within the team.
• 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 issues / processes to ensure compliance in applicable SOPs in the achievement of study milestones, data quality, and data integrity.

Qualifications:

• 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 three (3) years of related experience; clinical operations experience in a pharmaceutical or CRO setting preferred.

• Understanding of FDA regulations, GCPs and ICH guidelines is a must.
• Proactive, self-starter who possesses exceptional 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 Access, Visio or similar database a plus.

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer