Laboratory Coordinator jobs in Connecticut

Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Laboratory Project Coordinator.

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.

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 LIMS 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 teamwork by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will interact with as a regular part of the role responsibilities. Include any external interactions as appropriate.

Reports to Laboratory Sr. Safety Manager PCRU New Haven. Matrixed relationship with relevant PCRU study team members (clinical project managers, clinical coordinators, shift leaders, medical providers, and potentially study teams in Brussels, Belgium).

RESOURCES MANAGED

Financial Accountability

Helps determine laboratory costs for laboratory projects as needed.

Supervision

No direct reports. Is accountable for Laboratory components of all study projects.

PHYSICAL/MENTAL REQUIREMENTS

NA

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

NA

Work Location Assignment: On Premise

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

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: In person