Clinical Trials Project Lead

Updated: over 2 years ago
Deadline: 12 $76,574 - $107,481 per year; Oct 19, 2021

This competition is open to all applicants however, internal candidates and applicants who were former employees of the University of Alberta in the past 18 months will be given priority consideration before external candidates. Please indicate your internal status using the "Advertisement" drop down menu when applying.


This position has an initial term of one year with the possibility of extension and offers a comprehensive benefits package which can be viewed at: Faculty & Staff Benefits .

Established in 2009, the mission of the Quality Management in Clinical Research (QMRC) Office is to ensure clinical research at the University of Alberta is conducted according to the highest scientific and ethical standards, complies with local, national and international policies as well as governing statues and regulations and that internal quality systems are comprehensive, appropriate and effective. The QMCR Office provides services to faculty, clinicians, staff (both at the UofA and Alberta Health Services [AHS]), internal University of Alberta Offices (Deans, Department Chairs, Research Ethics Office, Research Services Office, Office of the Vice-President Research and Innovation) and external organizations (Alberta Health Services (AHS), the Northern Alberta Clinical Trials and Research Centre (NACTRC) - a joint venture of the University of Alberta (UofA) and AHS, and Alberta Clinical Research Consortium (ACRC), to ensure research quality review, management and reporting of compliance. 

Reporting to the Advisor, Quality Management in Clinical Research (QMCR), the Clinical Trial Project Lead is responsible for independently designing, managing, delivering and/or performing full clinical site monitoring services for multiple projects, which may include multiple services, be complex in nature and run on a multinational and international scale. This position is responsible for services including training, site/patient recruitment, site data/document management, supervision/monitoring of project site budgets, and regulatory compliance that align with SOPs, study guidelines and GCP best practices. The incumbent will be responsible for the development of project plans, protocols, CRFs (Case Report Forms), communications or other monitoring forms, documents and tools. The position will serve as the primary contact and represent the University's Quality Management in Clinical Research Unit by maintaining collaborative relationships with stakeholders.

Duties

Project Management Lead - 50%

Champions highly complex national and international designed clinical research trials and delivers project management leadership by initiating, conducting, reporting, and providing technical support to ensure successful completion.

  • Designs and oversees operational and quality plans including concept development, correlative and translational design, protocol and informed consent drafting, safety and regulatory document drafting, monitoring and quality plan drafting;
  • Monitors all internal and external resources and ensures optimal utilization to achieve all plans and assists with the development process of all clinical protocols and submit all protocols to management for approval;
  • Analyzes all project development plans and ensures computability into project implementation and monitors all materials for clinical trials and ensure compliance to project timeline;
  • Functions as liaison between Principle Investigators (Pl's), Clinical Research Associates (CRAs), industry sponsors, Regulatory Authorities and other functional teams, escalating concerns and issues to management as needed.
  • Participates and/or presents at study team, kickoff and investigator meetings and acts as primary contact to sponsors for all monitoring and project management related issues;
  • Develops projecU program infrastructure standard operating procedures, workflow processes and re-engineering processes in conjunction with the QMCR Quality Control Specialist and contributes to the ongoing review and modification to ensure continuity, relevancy and subject safety;
  • Communicates effectively by establishing strong working relationships with a diverse matrix of clinical trial sites, investigators, and other important stakeholders.

Scientific Operations - 25%

Develops, evaluates, enhances, and/or implements quality improvement practices, processes, procedures, or policies that have an impact on research operations.

  • Evaluates and manages all sites and vendor related issues, and simultaneously provides clinical guidance on aspects of the research studies and provides referral to QMCR, Health Research Ethics Board (HREB), and Vice-President Research and Innovation (VPRI) when appropriate;
  • Identifies and recruits site investigators, coordinates the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools;
  • Assesses site qualification potential, reviews study requirements, conducts pre-study visits and drafts pre-study evaluation reports and assesses the trial site and applicable personnel on an ongoing basis;
  • Ensures SOPs are in place to optimize study recruitment providing guidance to site teams of inclusion/exclusion criteria;
  • Collaborates/consults with researchers by reviewing, evaluating and making recommendations for projecU research program initiatives;
  • Contributes to the statistical analysis and data reporting documentation used in conjunction with QMCR Senior Manager;
  • Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies;
  • Demonstrates an understanding of the principles of quality assurance and continuous improvement in order to contribute to the mandate of QMCR by participating in professional activities related to clinical research practice and medicine.

Compliance Management - 25%

Advises research staff in scientific and procedural aspects of studies including methodologies on standards of care, informed consent procedures, or documentation procedures.

  • Supervises the conduct of clinical studies and acts as liaison between site personnel and the sponsor; performs monitoring and review of data flow from clinical sites; ensures compliance with protocols, regulatory requirements, and good clinical practices and writes follow-up visit reports;
  • Adheres to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures by tracking and reporting Serious Adverse Events;
  • Verifies the receipt, handling, accounting, storage conditions and availability of clinical products under investigation and liaises with external agencies to oversee distribution of supplies and study materials;
  • Prepares Case Report Forms, in-service and site support materials, study manuals and project newsletters specific to a clinical trial project including patient-consent process and investigator communication;
  • Drafts an appropriate intervention plan for the avoidance of redundant errors and deviations for review by management;
  • Ensures the quality of the project by performing verification of materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the project team;
  • Closes clinical studies, verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.

Qualifications

  • Minimum bachelor's degree in a sciences field such as biology, health, life sciences or bioengineering. A Masters degree or completion of additional clinical research education (e.g. ACRP, SoCRA) is an asset (a combination of education and experience will be considered);
  • Minimum of 4 years clinical trial operations including site monitoring and project management with a good track record of managing large and loosely scoped projects and being able to deliver strong results;
  •  Experience writing study protocols or other scientific documents;
  • Data management experience;
  • In depth knowledge of clinical trial and drug development processes: ICH-GCP, FDA and TPD regulatory requirements. Demonstrated ability to manage multiple projects and cross-functional teams;
  • Understanding of the regulatory context, good clinical practices and standard operating procedures;
  • Ability to build trust with site personnel and communicate with concerned personnel

COVID-19 Vaccination: Proof of full vaccination against COVID-19 in compliance with the University’s COVID-19 Vaccination Directive. Fully Vaccinated means a status an individual achieves 14 days after having received the recommended number of doses of a COVID-19 vaccine approved by Health Canada or the World Health Organization, and requires the individual to maintain the recommended number and type of vaccine doses as updated and required by Health Canada thereafter


Established in 2009, the mission of the Quality Management in Clinical Research (QMRC) Office is to ensure clinical research at the University of Alberta is conducted according to the highest scientific and ethical standards, complies with local, national and international policies as well as governing statues and regulations and that internal quality systems are comprehensive, appropriate and effective. The QMCR Office provides services to faculty, clinicians, staff (both at the UofA and Alberta Health Services [AHS]), internal University of Alberta Offices (Deans, Department Chairs, Research Ethics Office, Research Services Office, Office of the Vice-President Research and Innovation) and external organizations (Alberta Health Services (AHS), the Northern Alberta Clinical Trials and Research Centre (NACTRC) - a joint venture of the University of Alberta (UofA) and AHS, and Alberta Clinical Research Consortium (ACRC), to ensure research quality review, management and reporting of compliance.

Reporting to the Advisor, Quality Management in Clinical Research (QMCR), the Clinical Trial Project Lead is responsible for independently designing, managing, delivering and/or performing full clinical site monitoring services for multiple projects, which may include multiple services, be complex in nature and run on a multinational and international scale. This position is responsible for services including training, site/patient recruitment, site data/document management, supervision/monitoring of project site budgets, and regulatory compliance that align with SOPs, study guidelines and GCP best practices. The incumbent will be responsible for the development of project plans, protocols, CRFs (Case Report Forms), communications or other monitoring forms, documents and tools. The position will serve as the primary contact and represent the University's Quality Management in Clinical Research Unit by maintaining collaborative relationships with stakeholders.


Note: Online applications are accepted until midnight Mountain Standard Time of the closing date.

We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.



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