Lead Clinical Project Coordinator

4 weeks ago

Canada Pharmaceutical Research Associates, Inc Full time
Position Overview

As a Lead Clinical Project Coordinator, you will be part of a prominent and extensive clinical research organization, driven by healthcare insights.

Key Responsibilities

Your primary duties will include:

  • Overseeing and directing the operational execution of one or more clinical trials from initiation through to data release.
  • Ensuring quality control over the Contract Research Organization (CRO) and its deliverables associated with study execution.
  • Coordinating the management of a clinical trial from initiation through to data release and preparation for inspections, ensuring timely provision of high-quality study data.
  • Contributing to and assisting in the compilation of sections for Clinical Study Reports.
  • Providing leadership to teams in establishing realistic recruitment targets and delivery milestones, acting as the primary point of accountability for detailed study initiation and monitoring plans.
  • Serving as a core member of the Study Team and representing the CRO on matters related to study execution.
  • Collaborating with functional teams and directly with CRO line functions to address or escalate site-level issues.
  • Facilitating decision-making and working closely with the Clinical Project Manager to inform operational strategies.
  • Managing Study Management and overseeing all Study Management functions both internally and at the CROs.
  • Conducting operational management for one or more studies of moderate complexity, generally overseeing all aspects of assigned studies.
  • Accountable for developing realistic and detailed study initiation and monitoring plans.
  • Conducting country-level feasibility assessments in partnership with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and evaluating site activation plans.
  • Leading the study risk planning process in relation to site and subject considerations.
  • Coordinating study/protocol training and investigator meetings.
  • Developing and providing essential inputs to the Clinical Trial Budget (e.g., Per Subject Costs).
  • Accountable for delivering the study in accordance with approved plans.
  • Leading inspection readiness activities concerning study management and site preparedness.
  • Producing or reviewing model Informed Consent Documents (ICD) and study/country/site-specific ICDs, as appropriate.
  • Transforming the study design document into an approved protocol template while integrating feedback from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.).
  • Approving the Study Initiation, Study Monitoring, and protocol recruitment plans.
  • Overseeing drug supply management – managing the distribution of drug supplies to sites and setting up the Interactive Voice Randomization System with the Supply Chain Lead.
  • Reviewing consolidated Pre-trial assessment reports, feasibility outputs, and more.
  • May assist with study-level submission readiness.
Qualifications

Education:

  • Minimum of a Bachelor's degree.

Skills:

  • Extensive experience in global clinical trial/study management.
  • Working knowledge of Good Clinical Practices, monitoring, and clinical regulatory operations.
  • Proven experience in study management and leadership.
  • Demonstrated oversight of CROs.
  • Experience in managing Per Subject Costs, vendor and ancillary costs, and monitoring budget projections and expenditures.

What Pharmaceutical Research Associates, Inc. Offers:

Our success is driven by the quality of our workforce. We prioritize creating a diverse culture that rewards high performance and nurtures talent. Alongside a competitive salary, we provide a variety of additional benefits designed to support well-being and work-life balance for you and your family.

  • Various annual leave entitlements.
  • A range of health insurance options tailored to meet your and your family's needs.
  • Competitive retirement planning options to maximize savings and plan confidently for the future.
  • Global Employee Assistance Programme, offering 24-hour access to a worldwide network of independent specialized professionals to support your and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.

At Pharmaceutical Research Associates, Inc., diversity, inclusion, and belonging are integral to our culture and values. Our rich diversity fosters innovation, enabling us to better serve our people, patients, customers, and communities. We are proud of our diverse workforce and our commitment to creating an inclusive organization. We strive to provide a workplace free from discrimination and harassment, ensuring equal consideration for all qualified applicants.

If you require reasonable accommodations due to a medical condition or disability during the application process or to perform essential job functions, please inform us.

We encourage you to apply even if you do not meet all the requirements – you may be exactly what we are looking for.

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