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Associate Principal Investigator
San Diego - Intertek
Job Title: Associate Principal Investigator
Job Location: San Diego, California
Intertek Pharmaceutical Services is a Contract Research Organization (CRO) offering Good Laboratory Practice (GLP) services for bioanalysis of both large and small molecule drugs with expertise in Immunoassay and LC-MS/MS, supporting toxicokinetic (TK) / pharmacokinetic (PK), immunogenicity and biomarker studies. Our laboratory is located in San Diego, California in a facility spanning 46,000 square feet of laboratory, office and sample storage space streamlined to support preclinical and clinical bioanalysis. In 2015 the laboratory was significantly expanded to expedite delivery of fast and cost-effective bioanalysis for global clients.
The Associate Principal Investigator is responsible for performing all assigned and routine document related tasks in accordance with Intertek SOPs and relevant regulatory requirements to include Good Laboratory Practices (GLP). The Associate Principal Investigator is also responsible for ensuring that quality data is delivered to the client in a timely manner.
• Ensure that laboratory personnel are qualified on applicable bioanalytical procedure (BP) methods prior to performing assigned tasks.
• Collaborate with client services to monitor the status of each assigned project and communicate with the study director and/or sponsor contact with regards to the progress.
• Coordinate with lab personnel on troubleshooting assays and effectively communicate with the client.
• Ensure accurate inventory of supplies for laboratory operations is maintained to execute assay schedule.
• Initiate, prepare, and sign SOP and bioanalytical procedure deviation reports and notify the study director as applicable.
• Ensure the creation of administrative and project notebooks, client files, and setup of the LIMS for new projects.
• Communicate new projects/protocols and any updates to the Master Schedule to applicable Intertek personnel.
• Ensure the protocol and its amendments are provided to all involved in the study in a timely manner.
• Coordinate sample receipt, tracking, and storage, and ensure any necessary communications to the site or client. Assure that discrepancies are accurately reconciled and documented.
• Update the revenue tracker as needed to assure the accuracy of forecasting and monthly revenue.
• Create prep batches/run lists, worksheets, and/or plate setups in LIMS.
• Review assays according to Intertek SOPs and current regulatory guidelines.
• Ensure accurate record keeping with regards to sponsor's samples, data, and reports. Ensure that analysis is performed according to the protocol and the Sample Analysis Plan (SAP), if applicable.
• Ensure that data reduction, data review, and bioanalytical report creation is performed according to Intertek SOPs, and all are ready for QCC or QAU review.
• Respond to the QCC and QAU inspections and audit reports promptly, indicating the corrective actions.
• Coordinate the preparation and signature of bioanalytical reports and the GLP compliance statement. Ensure the suitability of the report for submission to the client and for applicable regulatory agency requirements.
• Responsible for the timely transfer of data and records to the client.
• Compose or revise SOPs and contribute to final written SOPs in the laboratory.
• Follow GLP guidelines and Intertek SOPs and maintain a safe working environment.
• Responsible for general lab safety with regard to employees and clients.
• Bachelor's Degree (BA or BS) required.
• 3+ years of relevant experience in data and/or project management preferred.
• Demonstrated ability to effectively communicate with clients.
• Demonstrated ability to multi task in a fast paced, high attention to detail environment.
• Effective time management and organization skills.
Intertek offers a salary and benefit package competitively placed within the local market. We promote a culture where motivated, customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. We offer medical, prescription, dental, vision, life and disability insurance plans, 401(k) with company match, paid time off (vacation, sick, holiday), Flexible Spending Account (FSA), Employee Assistance Program (EAP), tuition reimbursement, and more.
We are an Equal Opportunity Employer and do not discriminate against applicants due to veterans status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.
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