Laboratory Project Coordinator
- Employer
- Pfizer
- Location
- New Haven, Connecticut
- Start date
- Jul 30, 2021
View more
- Discipline
- Clinical, Clinical Project Management, Science/R&D, Laboratory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
ROLE SUMMARY
Accountable for the planning and Laboratory protocol adherence and data quality of assigned laboratory projects in the New Haven PCRU in accordance with scientific, medical and ethical principles and with GxP requirement guidelines. Therefore s/he will be the main contact person in the laboratory for any clinical study or assigned projects. Also accountable for data cache (study QC and reconciliation of issues) at study closeout and may assist in support of electronic notebooks or other digital applications, or data transfer requirements. Works with PCRU study team members or Biomarker Leads to execute clinical trials or external biomarker development that meet regulatory guidelines, project team timelines, and quality requirements. Serves as an expert to troubleshoot laboratory-based issues that arise in the preparation, conduct, close-out of clinical trials. Provides novel approaches to resolving problems and issues that may arise within the Safety or Biomarker Laboratories during assay conduct.
ROLE RESPONSIBILITIES
- Coordinates laboratory projects with all customers (organize laboratory project meetings, ensure clarity of laboratory processes) and organizes laboratory project planning and budget
- Reviews Laboratory protocols and provides feasibility assessments on the ability to perform laboratory requirements and procedures
- Develops and setup our laboratory capabilities and competencies required for conducting our laboratory activities in the PCRU BR in due time
- Ensures the Laboratory components of clinical trials are conducted according to the protocol requirement, objectives, and timelines
- Ensures that the assigned projects are carried out following GxP, scientific, medical, and ethical principles, within regulatory requirements/guidelines, and standard operating procedures
- Works closely and communicates with all stakeholders (PCRU colleagues & external vendors) for the management of the day to day study activities for immediate & medium/long term problem solving, ensuring that project milestones are met
- Overseeing the collection and documentation of assigned Laboratory study data
- Performs ongoing & regular quality reviews of our laboratory data for achieving audit-readiness
- Maintains quality processes and SOPs related to assigned projects and assists in continuous process improvement in our laboratory
- Supports the Laboratory planning and schedule aiming to forecast sufficient trained resources upfront Performs other related duties incidental to the work described herein.
- May support building of Electronic Notebook or other automated digital applications as assigned.
- May support data quality checks and data transmission processes as assigned.
BASIC QUALIFICATIONS
- Minimum of a bachelor’s degree in Medical Technology or other Health Science related discipline.
- American Society of Clinical Pathology (ASCP) certified.
- Minimum of 7 years of relevant work experience in pharmaceutical, hospital, or medical research.
- Knowledge of clinical trials.
- Working knowledge of GxP, GCP, CAP, and CLIA regulations.
- Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
- Working knowledge of Word, Excel, Teams, and Database applications
- Working knowledge of LIS systems and electronic notebooks
PREFERRED QUALIFICATIONS
- Understanding and demonstrated proficiency in handling laboratory projects.
- Knowledge of a pharmaceutical clinical research unit environment.
- Laboratory LIS system utilization.
- Basic knowledge of Sequel or similar programs. Ability to write scripts to resolve issues.
- Ability to challenge existing paradigms in clinical research and to encourage novel designs/ideas and research approaches to improve study conduct, data capture, retrieval and submission processes.
- Demonstrates team work by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.
Other Job Details:
- Eligible for Relocation Package: NO
- Eligible for Employee Referral Bonus: YES
- #LI-PFE
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