Research Associate II, BioAnalytical Sciences

Location:  San Rafael, California Category: Research

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 
 

The primary responsibilities of Sample Management Research Associate 1 (RA1) in the BioAnalytical Sciences Department are to create and maintain project clinical and non-clinical studies in the Laboratory Information Management System (LIMS) as a study sample coordinator, and to execute critical data transfers. The RA1 will interact with external personnel from clinical sites, collaborators, and contract research organizations, as necessary, and may train Research Technicians on sample processing activities and responsibilities. In addition, the RA1 will complete required documentation, verify documents for completeness and correctness, and collaborate with internal and external collaborators to reconcile sample discrepancies and confirm sample status after reconciliation is received. The RA1 may also receive and process specimens, enter study subject metadata, distribute specimens for testing, and ensure proper storage of specimens.

Responsibilities:

  • Create study designs for clinical and non-clinical studies, and assays in LIMS
  • Responsible for organizing studies in LIMS for proper specimen tracking and maintaining compliance
  • Participate in Project Team meetings as sample coordinator
  • Train Research Technicians in sample processing
  • Coordinate study sample receipt and management with Clinical Operations, Pharmacological Operations, Medical Affairs, and CROs
  • Process and track specimens throughout the sample chain of custody lifecycle from sample receipt through final disposition
  • Perform documentation according to applicable GLP regulations
  • Maintain study sample records and logbooks
  • Communicate in a professional manner via phone, correspondences and meetings
  • Maintain open communication with team members, analysts and managers to problem solve and expedite testing
  • Participate and contribute ideas in process improvement meetings
  • Maintain inspection readiness
  • Data Transfer collaboration by providing Visit Mapping information after reconciling related demographic data
Education:
  • Bachelor’s degree in Biology, Chemistry or a related scientific field
Experience:
  • Two years of relevant experience in a BioAnalytical, clinical or nonclinical laboratory
  • 1 year in sample coordination using LIMS, Electric Laboratory Notebook (ELN) and GXP documentation is preferred

  •  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


~BIO