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Clinical Operations Associate

Retrophin, Inc

San Diego, California
  • Clinical Operations
Retrophin, Inc
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Job Details

Position Summary

We are seeking a Clinical Operations Associate who has the ability to both prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment. 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 both the internal project team and the CROs.

Essential Functions:

  • Ensures that delegated components of clinical trials are executed to expected and specified quality standards.
  • 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.
  • Supports internal Clinical Operations in monitoring the implementation and progress of a clinical study.
  • Develops and maintains relationships with external vendors.
  • Collaborates with consultants and contractors to R&D.
  • Working closely with Clinical Operations, is responsible for coordination, tracking, and 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.
  • 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 VEEVA Platform and similar systems.
  • Coordinates project meetings, including scheduling and drafting and distribution of meeting agendas and minutes.
  • Supports the development and implementation of standard operating procedures and common work practices within the team.
  • Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.


  • 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.
  • Two to four (2-4) years of clinical operations experience in a pharmaceutical or CRO setting.
  • Familiarity with GCPs, ICH guidelines and FDA regulations is a plus.
  • Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
  • Good problem-solving skills, 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 Word, Excel, and PowerPoint, and some knowledge of Access or similar databases required.
  • Administrative or user knowledge of VEEVA Platform system preferred

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

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