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World Health Research

Research Site Start-up Specialist

  • Hamilton, ON, Canada

Full-time

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Job details

Job type
Full-time
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Experience
Recent (2 years) experience with clinical trials and/or large research studies, particularly in study start-up activities.
Posting language
English
Posted

Original job description

Job Description: Site Start-Up Specialist:

The World Health Research (WHR) Site Start-Up Specialist supports the study team (project manager, project coordinator, and administrative assistant), focused on overseeing and coordinating the initial phases of clinical trial operations, including site identification, feasibility assessments, regulatory submissions, and study initiation activities. The ideal candidate will possess strong organizational skills, attention to detail, and a collaborative mindset.

  1. The ideal candidate has knowledge of clinical research principles, regulatory guidelines, and industry best practices.
  2. The position requires the ability to work independently as well as collaboratively with cross-functional teams to ensure timely and accurate completion of tasks.

Key Responsibilities:

  • Collaborate with internal and external stakeholders to manage site identification, invitation, selection, and feasibility processes.
  • Prepare, review, and submit regulatory documents to ensure compliance with local, regional, and international guidelines.
  • Coordinate with clinical sites to facilitate contracts, budgets, and essential document collection.
  • Monitor and communicate progress of study start-up activities, identifying and resolving any issues or delays.
  • Ensure adherence to timelines, budgets, and regulatory requirements for study start-up activities.
  • Maintain and update databases, trackers, and documentation related to study start-up processes.
  • Develop regular newsletters and update the study websites.
  • Serve as the primary point of contact for study start-up matters for internal and external stakeholders.

Qualifications and Experience:

  1. Bachelor’s degree in health sciences or a related field.
  2. Recent (2 years) experience with clinical trials and/or large research studies, particularly in study start-up activities.
  3. In-depth knowledge of ICH-GCP, Health Canada Division 5, and clinical trial guidelines and processes.
  4. Strong communication, negotiation, and problem-solving skills.
  5. Proficiency in Microsoft Office Suite.
  6. Demonstrated strong initiative and drive and the ability to be self directed.
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More about this job

Responsibilities

Coordinate clinical trial site identification, selection, feasibility, regulatory submissions, contracts, budgets, and essential document collection. Track study start-up progress, resolve delays, maintain related records, create newsletters and website updates, and serve as the primary contact for start-up matters.

Requirements

Requires a bachelor’s degree in health sciences or a related field and recent experience with clinical trials or large research studies, particularly study start-up activities. Candidates should know ICH-GCP, Health Canada Division 5, and clinical trial processes, and demonstrate strong communication, negotiation, problem-solving, organizational, and self-direction skills, along with Microsoft Office proficiency.

Skills

  • Clinical Trial Start-Up
  • Site Identification
  • Feasibility Assessment
  • Regulatory Submissions
  • ICH-GCP
  • Health Canada Division 5
  • Clinical Site Coordination
  • Contract and Budget Coordination
  • Essential Document Collection
  • Stakeholder Communication
  • Project Coordination
  • Timeline and Budget Management
  • Problem-Solving
  • Negotiation
  • Microsoft Office
  • Database and Tracker Management

Visa sponsorship

Not detected in the job text

Categories

  • Healthcare
  • Science & Research
  • Administrative

Keywords

  • Clinical Research
  • Clinical Trials
  • Study Start-Up
  • Site Identification
  • Site Invitation
  • Site Selection
  • Feasibility Assessments
  • Regulatory Submissions
  • ICH-GCP
  • Health Canada Division 5
  • Clinical Trial Guidelines
  • Regulatory Compliance
  • Study Initiation
  • Clinical Sites
  • Contracts
  • Budgets
  • Essential Documents
  • Stakeholder Coordination
  • Study Timelines
  • Study Start-Up Trackers
  • Research Databases
  • Study Newsletters
  • Study Websites
  • Microsoft Office Suite
  • Research Services

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