Job Detail

Clinical Research Associate II (Quebec or Ontario)

Job Summary

Location

Kirkland QC

Posting date

Categories

  • Clinical data - Statistics - Biostatistics
  • Clinical research
  • Scientific and Regulatory affairs

Location : Quebec or Ontario

Status: 1 Regular Full Time & 1 Temporary Full Time (2 year)

 

ROLE SUMMARY:

The Clinical Research Associate II is responsible for the identification, evaluation, selection, initiation, monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.

The Clinical Research Associate II role is accountable for clinical trial monitoring and managing investigator site relationships to ensure effective delivery of clinical trials (e.g. site activation, enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site health), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders.

The Clinical Research Associate II is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with study team members as required in activities associated with the set-up, running and close out of a clinical trial.

ROLE RESPONSIBILITIES:

Clinical Trial Monitoring

  • Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from study start-up through database lock, ensuring relevant timelines and quality deliverables are met
  •  Identify, evaluate and select investigator sites as needed
  • Perform site qualification/Pre-Trial Assessment Visits and ensure selected sites have appropriate capabilities and access to patient populations to meet protocol and timeline requirements
  • Perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
  •  Conduct site initiation visits in collaboration with study team members as needed
  • Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.  Partner with study team to define and support recruitment initiatives at site level
  • Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
  • Provide support to investigator sites and study teams in preparation for and providing responses to site audits/inspections
  • Support study team as needed with Regulatory, Central, and Local Ethics Submissions and responses.
  • Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out visit within required timelines
  • Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.
  • Support database release as needed

Clinical/Scientific and Site Monitoring Risk:

  • Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
  • Interact with investigator site heath care professionals in a manner which enhances Pfizer's credibility, scientific leadership and in order to facilitate Pfizer's clinical development goals
  • Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
  • In partnership with appropriate study team members contribute to the study level risk plan; mitigate for known/anticipated risks proactively
  • Monitor site performance using appropriate tools and resources and take appropriate targeted action
  • Apply knowledge of data and analytics to target site level actions for mitigation and control
  • Identify and address Significant Quality Events or other quality issues at patient and/or site level
  • In collaboration with appropriate study team members, create and implement corrective actions and preventative actions (CAPA) as needed
  • May have delegated responsibility from the Director of Clinical Site Management
  • Train and coach Clinical Research Associates I and/or Clinical Research Site Assistants as assigned

QUALIFICATIONS:

  • Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
  • Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring with a Global Clinical Trial Experience
  • Experience in the development of study-related documents is beneficial
  • Required therapeutic experience in oncology (solid tumor, including tumor response using RECIST)
  • Preferred therapeutic specifically in immuno-oncology with experience in monitoring a) safety events commonly associated with immunotherapies and b) tumor response determinations using both RECIST and immune-related RECIST
  • Must be fluent in English and French

PHYSICAL/MENTAL REQUIREMENTS:

  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
  • Demonstrated knowledge of global and local regulatory requirements and understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
  • Demonstrated ability to participate and support sponsor regulatory interactions/inspections
  • Demonstrated knowledge of the processes around protocol design and feasibility assessment
  • Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:

  • Significant travel (60-80%) within area is required.  May require some international travel and some weekend travel
  • Valid driver's license

 

Pfizer is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Pfizer will accommodate the needs of applicants with disabilities throughout all stages of the selection process. Should accommodation during the recruitment process be required, please advise your Talent Acquisition representative.