Registered Nurse – Clinical Research

Full-time

Overview:

The research nurse is primarily responsible for study coordination and data management oversight. His/her central focus is on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. This position requires interactions with subjects, clinical research staff and staff from the regulatory and data management areas of the company.

Responsibilities:

  • Completes study visit activities including EKGs, phlebotomy(blood draws), and vital signs
  • Detailed understanding of Phase I-IV drug development
  • Participates from study initiation through the close-out process
  • Responsible for recruiting and scheduling of study participants
  • Conducts and assists with study procedures, including but not limited to the administration of investigational drugs, performance of investigational imaging procedures and lumbar punctures
  • May supervise other junior research staff

Qualifications

  • Current Connecticut state licensure as a registered nurse
  • Experience with EKG’s, Blood Draws, and taking Vital Signs
  • Bachelor’s Degree in registered nursing &/or equivalent experience in a related field
  • Knowledge of Good Clinical Practices (GCP) and other Regulations

Physical requirements/environmental factors:

  • Ability to lift 20-25 lbs
  • Travel to Investigator meetings may be required
  • Exposure to human bodily fluids

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Technical Project Manager – Image Analysis

Full-time

Overview:

The Technical PM is responsible for interfacing with Project Managers and Developers on a variety of imaging studies and technical projects. The Technical PM is expected to have a full understanding of all typical workflows within Invicro’s Image Analysis (IA) and Project Management groups. The Technical PM is also responsible for planning, executing, and finalizing solutions related to new and existing projects, phased functional enhancements, workflows, analysis integration methods, modules and services. Other duties may include editing or creation of SOPs, internal development tasks, and training employees on tools developed for project management.

Responsibilities:

  • Facilitate connections between the Project Management and Image Analysis teams
  • Testing, implementation, validation, and training of software tools developed for Project Management
  • Ensuring the quality of all processing and output materials
  • Editing and creation of SOPs
  • Effective communication both within the department as well as with other departments and other sites/sponsors
  • May work on supervised or open-ended development tasks

Qualifications and Skills:

  • Master’s Degree or Bachelor’s with 2+ years’ experience
  • Degree in physics, mathematics, engineering, or related field
  • Strong communication and problem-solving skills

Critical:

  • Coding/scripting experience (MATLAB, Python, or related)
  • Highly organized

Nice to have:

  • Imaging background
  • Project Management experience
  • Experience peripheral to pharma

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Senior Compliance Manager

Full-time

Overview:

The Senior Compliance Manager will provide direction for the development, execution, and compliance of the Company’s Quality Assurance program to comply with all appropriate quality regulations. The position is responsible for internal and external auditing and reporting on the management and/or performance of all GMP, GLP, GCP (GXP) QA functions. This position supports Invicro’s QA program, which is imperative to ensure adherence to federal, state and international regulations and standards.

Responsibilities/Knowledge Required:

  • Assist with inspection readiness, and regulatory inspections as needed
  • Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
  • Oversee the audit response and ensure acceptability of actions to address findings through the CAPA process
  • Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation)
  • Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.
  • Experience in vendor management (min. 5 years’ experience preferred)
  • Perform audits and help manage the qualification of external vendors to ensure compliance with applicable regulations and standards.
  • Draft, review or revise SOPs to assess consistency and compliance with regulatory requirements/internal standards
  • Attend cross-functional team meetings and provide guidance to staff based on interpretation of current regulations to ensure best practices including risk-based management
  • Perform root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
  • Work with the Director of Compliance to serve as a back-up and to help manage the Quality Management System and related processes.
  • Work with QA leadership to provide training, knowledge management, and strategic quality consultation to internal and external customers as needed.

Professional Competencies:

  • A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
  • Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
  • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
  • A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
  • Experience with using risk-based principles & decision making to ensure compliance at all stages of development
  • Proven track-record of leadership & building relationships with both internal & external customers
  • Effective communication and organizational skills
  • Strong oral and written skills

Education/Experience:

  • Bachelors level degree in a scientific or life sciences discipline
  • A minimum of 5+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role and compliance
  • CQA, or equivalent, certification preferred
  • 3-5 years management experience preferred

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Quality Assurance Associate – Chemistry

Full-time

Purpose of the position/Job Summary:

The QA Associate-Chemistry (External Manufacturing QA) is responsible for performing various QA analyses on company products, ensuring the quality and integrity of the finished product, production/QC data in support of CMC and other FDA submission documents.

Scope & Impact:

This individual will work closely with Regulatory Affairs and the Chemistry groups to enhance quality systems and methods for documentation of the adherence to company procedures, Good Clinical Practice, Good Manufacturing Practice, 21CFR Part 212 and other regulatory requirements. The incumbent will also interact with external site manufacturing personnel. Research involving human participants, and the development and use of radio-pharmaceuticals, requires the timely and precise organization of regulatory documents.  It is imperative that regulatory documentation reflect the changing requirements of regulations and Invicro’s interpretation of those changes.  This position will help ensure that all chemistry products (External Manufacturing) for human use are safe and of high quality.

Major responsibilities:

  • Review and approve external manufacturing batch records.
  • Track and organize documents for batch record closure.
  • Organize external manufacturing documents.
  • Track documents for localization distribution.
  • Track OOS/deviation findings, report noticed trends to supervisor. Support company CAPA program.
  • Assist in audit activities as required.
  • Assist in review of external manufacturing procedures.
  • Ensure all external manufacturing processes are covered in SOPs and WIDs and maintained in accordance with regulations.
  • Assist in chemistry technology transfer and process validation activities.
  • Support Project Management’s interactions with external manufacturing sites.
  • Assist in assuring consistency between sponsor’s and external manufacturing sites’ quality agreements.
  • Assist in updating External Manufacturing QA documents at appropriate review cycles.
  • Maintain current documentation of training for external manufacturing sites.
  • Keep current with industry guidelines and regulations.
  • Other tasks as assigned by supervisor.

Qualifications:

Required:

  • Minimum of a Bachelor’s degree with 2-years’ experience in a comparable environment.
  • Must be highly motivated and detail oriented.

Preferred:

  • Biology or Chemistry background

Unique Department Requirements:

  • Works in an environment with radiopharmaceuticals
  • Due to location of manufacturing sites, there will need to be some flexible shift schedule requirements.

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.