Research Associate, Clinical II
781 Lincoln Avenue San Rafael, CA 94901
Bayside Solutions is seeking a Research Associate, Clinical II to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Research Associate, Clinical II:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Primary point of contact on all biospecimen management activities across all assigned clinical trial studies.
- Collaborate with relevant vendors, or Clinical Operations (CLO) vendor specialist, 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 during early planning phases, and continue to participate in study team meetings on an ad-hoc basis throughout the life of a study.
- 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 early on 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 and MAF study/program is set-up in the CBMS: Labmatrix prior to First Patient In (FPI).
- Participate in introductory call with chosen lab vendors, along with any other calls relevant to biospecimen management.
- Participate in study-specific protocol working group.
- 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 discrepancies to CBM Manager.
- Collaborate with Clinical Data Management (CDM) to align on CDM schedule of events regarding vendor transfer specification timing and development.
- Provide input for vendor data transfer specifications and work with CBMS: Labmatrix system owner to determine system compatibility for accurate data tracking.
- 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).
- Create any study specific biospecimen disposal requests and escalate as appropriate.
- Participate in CBM functional improvement projects, as needed.
- Conduct all on-study tracking of specimens – this includes gathering input from study team members and relevant vendors.
- Consult on training documentation for all responsible parties (study monitors/CRO partners, investigative sites as appropriate) on the biospecimen management procedures and the proper completion of biospecimen transfer documents.
Summary of Qualifications:
- BA/BS in life sciences or related degree.
- Experience in lieu of education accepted.
- 2-5 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories).
- 3 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations.
- Able to 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
- Understanding of biospecimen management, i.e., biospecimen collection, processing, storage and shipping.
- Understanding informed consent and its impact on biospecimen management.
- Understanding of specialty or central lab handling of biospecimens and related timelines.
- Solid understanding of GxP principals and how they impact biospecimen operational activities.