Lab Project Coordinator Preceptor - New Haven, United States - Pfizer

Pfizer

Verified Company

New Haven, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

How You Will Achieve It

Train and support Brussels Laboratory Project Coordinators on the following responsibilities:

Supports Brussels Laboratory Project Coordinators to coordinate 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 laboratory capabilities and competencies required for conducting 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 laboratory data for achieving auditreadiness
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
May support data quality checks and data transmission processes as assigned.

Qualifications:

Must-Have

Minimum of a bachelor's degree in Medical Technology or other Health Science related discipline.
American Society of Clinical Pathology (ASCP) certified.
Minimum of 6 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 LIMS systems and electronic notebooks

Nice to Have

Minimum of a bachelor's degree in Medical Technology or other Health Science related discipline with 4+ years of experience.
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.

PHYSICAL/MENTAL REQUIREMENTS

NA

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Early morning hours to collaborate with Brussels colleagues.

Other Job Details:

Eligible for Employee Referral Bonus
NOT Eligible for Relocation Assistance

Work Location Assignment:
On Premise

On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site

Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.

These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure.

Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.

Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.

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