Clinical Research Site Assistant

April 24 2019
Categories Pharma, Biotech, Sciences, R&D, Research and development, Clinical research, Pharma, Biotech, Sciences, R&D
Kirkland, QC

Status: Temporary, Full Time (18 - 24 months)

Role Summary

The Clinical Research Site Assistant is responsible for supporting operational activities related to site evaluation, activation, and initiation, monitoring and close out for assigned investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

Role Responsibilities:

Clinical Trial Site Activation & Conduct

  • Assist with study site activation activities and coordinate operational activities to ensure timely site activation.
  • Register investigator sites in Pfizer registries as required.
  • Supports and/or coordinates central Investigator Review Board (IRB) submissions when needed.
  • Work with investigator sites to complete critical information for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
  • Support local IRB workflow from submission through approval and support reporting of safety information.
  • May facilitate coordination of study team responses to the IRB.
  • Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.
  • Communicate site approvals to relevant study team members.
  • Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
  • Work with investigator sites to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.
  • Submit within required timeframes all needed documentation, updates and tracking including but not limited to Trial Master File documentation, site activation status, protocol amendment status
  • Accurately update and maintain clinical systems that track site compliance and performance within project timelines.
  • Problem solve identified issues with appropriate timely escalation to study team.
  • In collaboration with stakeholders, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.
  • Maintain administrative and Study files and assist with periodic review of study files for accuracy and completeness.
  • Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections.

Communication

  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.

Clinical Trial Site Support

  • As needed, perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.
  • In collaboration with stakeholders, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation.
  • In collaboration with stakeholders, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.
  • Facilitate the submission of all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, monitoring visit reports, site visit follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics.
  • Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues.
  • Assist to resolve data queries within required timelines; support database release as needed.

Qualifications

  • School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor's degree in life sciences preferred.
  • Minimum 2 years relevant experience in clinical site management.
  • Experience in study activation and site management is an asset.
  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
  • Must be fluent in English.
  • For individuals based in Canada: Bilingualism (French, English) is an asset.

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.
  • Demonstrated understanding of key operational elements of a clinical trial (e.g., study start-up, conduct, close-out activities, reporting, etc.).
  • Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements.  Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
  • Proven ability to work independently and also as a team member.
  • Ability to organize tasks, time and priorities, ability to multi-task.
  • Understand basic medical terminology, GCP requirements and proficient in computer operations.
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
  • Travel anticipated at 20% within area.  May require some international travel.

Pfizer 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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