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 Research Associate, Clinical II is specifically responsible for the following tasks:
- Primary point of contact on all biospecimen management activities across 1-2 assigned clinical trial programs
- Collaborate with relevant vendors, study management and BioMarin scientists as needed, on any biospecimen related logistics, issues and queries
- Act as point of contact for all study team requests, lab queries and issues regarding biospecimen management throughout life of assigned studies; participate in study team meeting and provide appropriate guidance for biospecimen-related activities
- Provide input to study team for development of feasibility assessments for relevant biospecimen processing, collection, storage, and shipping activities to ensure sites and labs can meet biospecimen-handling needs of the study
- Participate in study team meetings as a standing member
- Review biospecimen handling sections of ICF template; provide input and guidance to study team on any site-specific modifications to ICF
- Update biospecimen consent tracker with relevant ICF information and document any issues impacting ability to collect, store, or use biospecimens in CBMS: Labmatrix
- Provide biospecimen-related input into vendor contracts, SOWs, lab specifications, laboratory manuals, manifest, and other relevant documents in the contracting process, including an agreement that the labs will adhere to biospecimen handling specifications as entered into CBMS: Labmatrix
- Ensure that each assigned CLO (Clinical Operations) and MAF (Medical Affairs) study/program is set-up in the CBMS: Labmatrix prior to First Patient In (FPI).
- Participate in regularly scheduled calls with chosen lab vendors, along with any other calls relevant to biospecimen management
- Manage biospecimen tracking and reconciliation activities for all active studies in CBMS: Labmatrix, and ensure that these activities are successfully updated before the status of study is transitioned to closed
- Act as the first point of contact for sample request fulfillments for assigned study exploratory/assay development/health authority requests.
- Review shipping requirements
- Participate in the cross-functional meetings to consult on decisions regarding biospecimen collection, kit design, shipping schedule, and data deliverables
- Develop a Project Specific Scope (PSS) between the external biorepository and BioMarin, which will be included in the Project Operation Procedure (POP)
- Participate in CBM functional improvement projects, as needed
- Input and maintain all biospecimen-relevant information into CBMS: Labmatrix for each assigned clinical trial study, i.e., outlining biospecimen stakeholder contacts, number and quantity of each biospecimen collected as related to the study’s schedule of events, any unique biospecimen handling or operational requirements, including the details of testing destinations and related shipping requirements
- Responsible for documenting and escalating any unresolved biospecimen-related issues, including disposition requests and discrepancies, to the CBM Manager
- Provide input for vendor data transfer specifications and work with CBMS: Labmatrix system owner to determine system compatibility for accurate data tracking
- Conduct all on-study tracking of specimens – this includes gathering input from study team members and relevant vendors
Individuals in the Research Associate, Clinical II role are expected to demonstrate foundational Communication, Leadership, and Problem-Solving skills and advanced Teamwork skills, including:
- Capable of leading cross-functional discussions and decisions
- actively contributing to team definition of goals, roles and tasks
- proactively expanding one’s network and work relationships outside the department
- ability to create inclusive and collaborative team and meeting environments
- ability to recognize and articulate and prioritize key issue that arise based on understanding of objectives
- ability to analyze and evaluate problems and seek-out and recommend possible solutions
- leveraging data effectively to communication points of view and influence outcomes
- ability to manage multiple tasks concurrently while adhering to timelines
- BA/BS in life sciences or related degree. Experience in lieu of education accepted.
- 4 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories)
- 2 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations
- Experienced in the following software: Microsoft Office Products, Visio, Project Management, SharePoint and Labmatrix
- The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
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.