ABOUT OUR CLINIC
Alzheimer's disease (AD) is the most common type of dementia, making up approximately 70% of all cases. Those over the age of 65 are at a higher risk to develop AD. It diminishes cognitive, verbal and physical abilities by destroying brain cells. This in turn affects our ability to think, to learn new things, and to remember. Many scientific experts are working to ameliorate our understanding of this devastating disease, thus searching to find more effective treatments.
Our clinics partner with pharmaceutical companies to conduct Phase II and III clinical trials for Alzheimer's Disease. Our unique contribution will revolutionize the fight against the disease. We provide care to patients, generate knowledge for the scientific community, continue to improve support, and access to clinical research.
SUMMARY
Under the authority of the Director of Clinical Research Operations, the incumbent is responsible for the implementation and execution of the procedures in research protocols, including support in the development, organization, management, and follow-up of research programs. This position is also responsible for providing administrative service in terms of development, organization, management, and follow-up of various research programs.
SPECIFIC TASKS
Master the latest versions of documents related to the research programs
Participates in the creation and verification of the file source template for each research program
Prepare and completes the subject's source files for study visits of the research programs and ensure follow-up and final approval of the subject's study source files with the PI/Sub-I
Ensure the planning and smooth running of visits related to research programs
Write study visit summary notes and has them approved by PI/Sub-I
Dispense study medication
Ensure subject's compliance to study medication
Master all aspects of the study subject source file documentation as per protocol
Ensure the remittance and follow-up of reimbursements for study subjects and their study partners
Create, maintain and follow-up on various study logs (i.e. study statistics, reimbursements, )
Respond to queries and follow-ups following visits by study monitors
Complete various medical forms (i.e. laboratory , MRI , PET, etc.)
Update electronic patient records
Collaborate with various study partners (i.e. monitors, pharmacists, suppliers, )
Maintain up-to-date training specific to the various research programs as well as general training
Develop tools and work methods (tables, documents, statistics, )
Perform work in accordance with the provisions of the Occupational Health and Safety Act and Regulations and all company policies and procedures related to Occupational Health and Safety.
Perform other related duties as assigned
REQUIREMENTS
Vocational Training
Is a member of good standing in the College of Nurses of Ontario
A Post-Secondary Degree or Diploma in Nursing is required, or a combination of education, training and experience deemed equivalent
Experience
A minimum of two (2) years of experience in acute care including intravenous placement and management of discomfort and allergies
Experience in medical research would be an asset
Skills, Abilities and Competencies
Knowledge of current computerized systems (MS Office Suite).
Good oral and written communication skills in French and English.
Mastery of good puncture and infusion techniques.
Ability to manage priorities.
Offering service adapted to the target clientele.
Ability to work under pressure.
Sense of organization and time management.
Adapting to change.
Thoroughness.
Team spirit.
Versatility.
Resourcefulness.
Responsible.
Professionalism.
High quality in terms of confidentiality and discretion.
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AU SUJET DE LA CLINIQUE
La maladie d'Alzheimer (MA) est le type de demence le plus courant, representant environ 70 % de tous les cas. Les personnes agees de plus de 65 ans courent un risque plus eleve de developper la MA. Elle diminue les capacites cognitives, verbales et physiques en detruisant les cellules du cerveau. Cela affecte a son tour notre capacite a penser, a apprendre de nouvelles choses et a nous souvenir. De nombreux experts scientifiques s'efforcent d'ameliorer notre comprehension de cette maladie devastatrice et cherchent ainsi a trouver des traitements plus efficaces.
Nos cliniques s'associent a des societes pharmaceutiques pour mener des essais cliniques de phase II et III sur la maladie d'Alzheimer. Notre contribution unique va revolutionner la lutte contre la maladie. Nous fournissons des soins aux patients, generons des connaissances pour la communaute scientifique, continuons a ameliorer le soutien et l'acces a la recherche clinique.
SOMMAIRE DE LA FONCTION
Sous l'autorite du directeur des operations de recherche clinique, le titulaire est responsable de la mise en oeuvre et de l'execution des procedures des protocoles de recherche, y compris le soutien au developpement, a l'organisation, a la gestion et au suivi des programmes de recherche. Ce poste est egalement responsable de fournir un service administratif en termes de developpement, d'organisation, de gestion et de suivi de divers programmes de recherche.
TACHES SPECIFIQUES
Maitrise les dernieres versions des documents relies aux programmes de recherche
Participe a la creation et a la verification des documents sources pour chaque programme de recherche
Prepare et complete les dossiers sources des sujets pour les visites d'etude des programmes de recherche et assure le suivi et l'approbation finale des dossiers sources des sujets avec le PI/Sub-I
Assure la planification et le bon deroulement des visites liees aux programmes de recherche
Redige les notes d'evolution des visites d'etude et les fait approuver par le PI/Sub-I
Dispense le traitement de l'etude
S'assure que le sujet respecte le traitement de l'etude
Maitrise tous les aspects de la documentation du dossier source du sujet de l'etude conformement au protocole
Assure la remise et le suivi des remboursements pour les sujets de l'etude et leurs partenaires de l'etude
Cree, maintient et suit les differents registres de l'etude (statistiques de l'etude, remboursements, etc.)
Repond aux questions et assure le suivi apres les visites des moniteurs d'etude
Rempli divers formulaires medicaux (laboratoire, IRM, TEP, etc.)
Met a jour les dossiers electroniques des patients
Collabore avec les differents partenaires de l'etude (moniteurs, pharmaciens, fournisseurs, etc.).
Maintient a jour les formations specifiques aux differents programmes de recherche ainsi que les formations generales
Elabore des outils et des methodes de travail (tableaux, documents, statistiques, etc.).
Effectue le travail conformement aux dispositions de la loi et des reglements sur la sante et la securite au travail et a toutes les politiques et procedures de l'entreprise relatives a la sante et a la securite au travail.
Effectue d'autres taches connexes assignees.
EXIGENCES
Formation professionnelle
Etre membre en regle de l'Ordre professionnel des infirmieres et infirmiers de l'Ontario
Un baccalaureat ou diplome en soins infirmiers est requis, ou une combinaison
Experience
Un minimum de deux (2) annees d'experience en soins actifs, y compris l'installation intraveineuse et la gestion de l'inconfort et des allergies.
Une experience en recherche medicale serait un atout.
Aptitudes, habiletes et competences
Connaissance des systemes informatises courants (Suite MS Office)
Bonne capacite a s'exprimer oralement et par ecrit en francais et en anglais
Maitrise de bonnes techniques de ponction et de perfusion
Capacite a gerer les priorites
Offrir un bon service adapte a la clientele cible
Capacite a travailler sous pression
Sens de l'organisation
Adaptation aux changements
Minutie
Esprit d'equipe
Polyvalence
Debrouillardise
Responsable
Professionnalisme
* Grande qualite en matiere de confidentialite et de discretion
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