Principal Investigator

Principal Investigator

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Job Description

The Principle Investigator (PI) is responsible for supporting scientifically effective and timely definition, set-up and completion of bioanalytical sample analysis studies, including authoring sample analysis plans and reviewing study reports. The Principle Investigator interfaces with external client and their toxicological or clinical partners to scope and define projects; and partners with Method Development and Validation Scientists and Laboratory Scientists to verify the scientific integrity of the data and confirm that procedures comply with internal and/or sponsor Standard Operating Procedures (SOPs) and regulatory requirements. The Principle Investigator serves as the primary Sponsor contact and manages Sponsor relationships as assigned, conducts work assignments in alignment with Sponsor specifications and timelines. Position is in St. Charles, MO.

• Serves as a key point of contact for new and existing customers.
• Manages project flow from project initiation through closeout while monitoring study for contractual adherence.
• Responsible for interface with Business Development to ensure change orders are timely if needed.
• Creates Method Validation Plans and manages amendments
• Creates sample analysis outlines and manages amendments.
• Reviews sample analysis/validation data and reports in support of non-regulated and regulated methods.
• Assures the quality of the data and compliance with applicable SOPs and regulatory requirements.
• Develops and maintains good working relationships with Sponsors, interfacing with Business Development, and Scientists to communicate and meet Sponsor needs and timelines, while providing technical information and resolving problems.
• Provides guidance on analytical issues, project technical requirements, design and logistics,.
• Organizes resource allocation/scheduling, contributes to company forecasts and revenue recognition based on project specifications and timelines.
• Designs and improves processes and procedures to increase efficiency, productivity, and quality
• Travel as needed to visit Sponsor and attend scientific meetings and workshops.
• Arranges specimen and data handling for all services
• Transfers reports to customers per agreements
• Oversees study records, data and sample storage
• Coordinates transfers of hard copy project records to Quality for archiving
• Maintains accurate client databases
• Supports client audits
• Assists with the writing of company SOPs
• Applies GxP in all areas of responsibility, as appropriate
• Works effectively as a member of a team, under minimum direction to achieve client and business deadlines.
• Attends internal and external training courses.
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• Conducts all activities in a safe and efficient manner
• Adjusts work hours as needed to meet client deadlines
• Adheres to site employee health and safety (EHS) requirements
• Performs other duties as assigned

Qualifications

• Knowledge of current United States FDA requirements and guidance on bioanalytical method development and sample analysis, familiarity with OEDC and ICH requirements, and current best practices in bioanalysis.
• Knowledge of preclinical and clinical drug development, clinical study designs and procedures.
• Experience in an FDA or ISO regulated industry within cGMP or GLP environment
• Experience in a Contract Research Organization
• Planning/Organization - Ability to manage multiple projects and tight deadlines, with a potentially heavy workload; willing to seek additional resources if needed to meet deadlines.
• Problem Solving – Skilled in diagnosing and evaluating problems, thinking “outside the box”, interfacing with internal staff, Sponsors and Vendors and working jointly to achieve a solution.
• Written Communication – Excellent writing ability for preparation of study reports, papers, SOPs and communications with Sponsors.
• Oral Communication – Presents concepts logically and in an organized fashion; listens and responds well to questions; demonstrates presentation skills; participates in meetings
• Professionalism – Reacts well under pressure; treats Sponsors and co-workers with respect, regardless of their status or position; communicates with tact; follows through on commitments; accepts responsibility for own actions.
• Adaptability – Manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events
• Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others’ views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives
• Ethics – Treats people with respect; keeps commitments; inspires the trust of others; works with integrity and ethically; upholds organizational values
• Judgment – Displays ability to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions; includes appropriate people in decision-making process; makes timely decisions
• Computer Skills – Strong working knowledge of Microsoft Office applications, particularly Word, Excel, Outlook, and PowerPoint; Watson LIMS; required use of IDBS Electronic Laboratory Notebook as core laboratory tool (after training) for all lab activities

• Bachelor's Degree in a science related field desired or equivalent work experience.
• More than 2 years’ lab, program management and data review experience
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is full-time, Monday - Friday 8:00am - 4:30pm. Candidates currently living within a commutable distance of St. Charles,MO are encouraged to apply. Relocation reimbursement available for the right candidate.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays