Assistant Laboratory Project Coordinator

Role Summary

As an Associate Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will have the important role to learn and assist in the lab project coordinator role at the New Haven PCRU.

You will assist the Laboratory Project Coordinator in study planning, Laboratory protocol adherence, and data quality review of assigned laboratory clinical trials in the New Haven PCRU and grow to monitor studies independently. Use scientific, medical and ethical principles and with GxP requirement guidelines in the review of clinical trial data. S/he will be the main contact person in the laboratory for any clinical study or assigned projects and will assist study teams to closeout clinical trial data in a timely manner. Also accountable for data cache (study QC and reconciliation of issues) at study closeout and may assist in support of electronic systems or applications, or data transfer requirements. Works with PCRU study team members to execute clinical trials or that meet regulatory guidelines, project team timelines, and quality requirements. Effectively uses electronic systems to provide end-to-end tracking of clinical trial samples. Involved in the creation of Lab Manuals for clinical trials. Serves as an expert to troubleshoot laboratory-based issues that arise in the preparation, conduct, close-out of clinical trials.

Role Responsibilities

• Coordinates laboratory projects with all customers (organize laboratory project meetings, ensure clarity of laboratory processes) and organizes laboratory project planning and budget.
• Creates study-based Lab Manuals
• Reviews Laboratory protocols and provides feasibility assessments on the ability to perform laboratory requirements and procedures.
• 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
• Supports the Laboratory planning and schedule aiming to forecast sufficient trained resources.
• 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

• Associate or Bachelor's Degree in Health Science related discipline preferred.
• Minimum of 5-7 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 Cerner LIS and Electronic Notebook.

Preferred Qualifications

• Understanding and demonstrated proficiency in handling laboratory clinical trial data and samples.
• Knowledge of a pharmaceutical clinical research unit environment.
• 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 teamwork by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.

PHYSICAL/MENTAL REQUIREMENTS

Ability to spend extended time with computer use, ability to perform calculations, and review complex spreadsheet data.

Work Location Assignment:New Haven, CT

*Last date to apply is November 28, 2023*

The annual base salary for this position ranges from $62,800.00 to $104,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development