Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Role:

CRA Level I/II

Location:

CAN, Toronto- Remote

Experience Requirements:

Previous Clinical Monitoring; on site or Remote

(REQUIRED)

Travel- up to 80%

(REQUIRED)

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Location/Division Specific Information

Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

A day in the Life:

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.

Keys to Success:

Education

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Experience

Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license where applicable.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

Basic medical/therapeutic area knowledge and understanding of medical terminology Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents Good oral and written communication skills, with the ability to communicate effectively with medical personnel Good interpersonal skills Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues Good organizational and time management skills Ability to remain flexibile and adaptable in a wide range of scenarios Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manage Risk Based Monitoring concepts and processes Ability to work in a team or independently as required Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills

Work Environment

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments. This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.

Details du poste:

Poste :

CRA Niveau I/II

Lieu :

Canada

,

Toronto- a distance

Experience requise :

Experience anterieure en surveillance clinique ; sur place ou a distance

(OBLIGATOIRE)

Deplacements : jusqu'a 80 %

(OBLIGATOIRE)

Chez Thermo Fisher Scientific, vous decouvrirez un travail significatif ayant un impact positif a l'echelle mondiale. Rejoignez nos collegues pour donner vie a notre mission - permettre a nos clients de rendre le monde plus sain, plus propre et plus sur. Nous fournissons a nos equipes les ressources necessaires pour atteindre leurs objectifs de carriere individuelle tout en faisant progresser la science par la recherche, le developpement et la livraison de therapies revolutionnaires. Avec des essais cliniques menes dans plus de 100 pays et le developpement continu de nouveaux cadres pour la recherche clinique a travers notre portefeuille de recherche clinique PPD, notre travail couvre les services de laboratoire, d'essais cliniques numeriques et decentralises. Votre determination a fournir qualite et precision ameliorera les resultats de sante dont dependent les personnes et les communautes - maintenant et a l'avenir.

Informations specifiques sur le lieu / division

Nos collegues mondiaux des Operations Cliniques au sein de nos services de recherche clinique PPD fournissent un support complet pour les essais cliniques, depuis le demarrage de l'etude jusqu'a la surveillance et la cloture de l'etude, sur des contrats commerciaux et gouvernementaux. Ensemble, nous aidons les clients a definir et developper des programmes cliniques, a minimiser les retards et a executer des etudes cliniques de haute qualite et rentables.

Decouvrez un Travail Impactant :

Realise et coordonne tous les aspects du processus de surveillance clinique et de gestion de site. Effectue des visites a distance ou sur site pour evaluer la conformite aux protocoles et aux reglementations, et gere la documentation requise. Gere les procedures et les lignes directrices provenant de differents sponsors et / ou environnements de surveillance (c'est-a-dire FSO, FSP, gouvernement, etc.). Agit en tant que specialiste des processus de site, en s'assurant que l'essai est conduit conformement au protocole approuve, aux lignes directrices ICH-GCP, aux reglementations applicables et aux SOP pour garantir les droits, le bien-etre des sujets et la fiabilite des donnees. Assure la preparation aux audits. Developpe des relations collaboratives avec les sites d'investigation. Les taches et responsabilites detaillees assignees a ce role sont decrites dans la matrice des taches.

Une journee type :

Surveille les sites des investigateurs avec une approche de surveillance basee sur les risques : applique l'analyse des causes profondes (RCA), la pensee critique et les competences en resolution de problemes pour identifier les defaillances des processus du site et les actions correctives / preventives pour assurer la conformite du site et reduire les risques. Assure l'exactitude des donnees grace a l'examen des SDR, SDV et CRF, selon les activites de surveillance sur site et a distance Evalue le produit d'investigation par l'inventaire physique et l'examen des dossiers Documente les observations dans des rapports et lettres en utilisant des normes d'ecriture commerciale approuvees et dans les delais impartis. Signale rapidement les deficiences et problemes observes a la direction clinique et suit toutes les issues jusqu'a leur resolution Peut maintenir un contact regulier entre les visites de surveillance avec les sites d'investigation pour confirmer que le protocole est suivi, que les problemes identifies precedemment sont resolus et que les donnees sont enregistrees en temps voulu. Effectue les taches de surveillance conformement au plan de surveillance approuve. Participe au processus de paiement des investigateurs. Assume une responsabilite partagee avec les autres membres de l'equipe projet pour la resolution des problemes et des constatations. Enquete et suit les constatations le cas echeant Participe aux reunions des investigateurs selon les besoins. Peut aider a identifier les investigateurs potentiels en collaboration avec l'entreprise cliente pour assurer l'acceptabilite des sites d'investigation qualifies. Initie les sites d'essais cliniques selon les procedures pertinentes pour assurer la conformite avec le protocole, les obligations reglementaires et ICH GCP, en faisant des recommandations lorsque necessaire. Effectue la cloture de l'essai et la recuperation des documents d'essai S'assure que les documents essentiels requis sont complets et en place, conformement a ICH-GCP et aux reglementations applicables. Effectue des revues de dossiers sur site selon les specifications du projet Fournit un suivi de l'etat de l'essai et des rapports de progression a l'equipe selon les besoins. S'assure que les systemes d'etude sont complets, exacts et mis a jour selon les conventions d'etude convenues (par ex. Systeme de gestion des essais cliniques) Facilite la communication efficace entre les sites d'investigation, l'entreprise cliente et les equipes de projet internes par contacts ecrits, oraux et / ou electroniques. Repond aux exigences / audits / inspections de l'entreprise, du client et des reglementations applicables Maintient et complete les taches administratives telles que les rapports de depenses et les feuilles de temps en temps opportun Contribue a l'equipe projet en aidant a la preparation des publications / outils du projet et en partageant des idees / suggestions avec les membres de l'equipe. Contribue a d'autres travaux de projet et initiatives d'amelioration des processus, selon les besoins

Cles du succes :

Education

Diplome de baccalaureat dans un domaine des sciences de la vie ou certification en soins infirmiers enregistree, ou equivalent, ainsi qu'une qualification academique / vocationnelle formelle pertinente

Experience

Experience minimale de surveillance clinique fournissant les connaissances, competences et capacites pour effectuer le travail (comparable a 2 ans) dans un environnement clinique ou l'experience est acquise dans les essais cliniques, la terminologie medicale, la recherche medicale, la recherche clinique ou les sciences de la sante, ou experience dans un domaine des sciences de la sante avec une formation formelle en terminologie medicale et en anatomie Permis de conduire valide

Dans certains cas, une equivalence, consistant en une combinaison de formations et / ou d'experiences directement liees, sera consideree comme suffisante pour qu'un individu reponde aux exigences du poste.


Connaissances, competences, capacites

Connaissance de base des domaines medicaux / therapeutiques et comprehension de la terminologie medicale Capacite a acquerir et maintenir une connaissance pratique des ICH GCP et des reglementations applicables ainsi que des documents proceduraux Bonnes competences en communication orale et ecrite, avec la capacite de communiquer efficacement avec le personnel medical Bonnes competences interpersonnelles Capacite a maintenir l'attention sur le client en utilisant de bonnes competences d'ecoute, une attention aux details et la capacite de percevoir les problemes sous-jacents des clients Bonnes competences en organisation et gestion du temps Capacite a rester flexible et adaptable dans une large gamme de scenarios Competences developpees en pensee critique, y compris mais sans s'y limiter : esprit critique, investigation approfondie pour une analyse appropriee des causes profondes et resolution de problemes Capacite a gerer les concepts et processus de surveillance basees sur les risques Capacite a travailler en equipe ou de maniere independante selon les besoins Bonnes competences informatiques : solide connaissance de Microsoft Office et capacite a apprendre a utiliser les logiciels appropries Bonnes competences en anglais et en grammaire

Environnement de travail

Thermo Fisher Scientific valorise la sante et le bien-etre de ses employes. Nous encourageons et soutenons les individus a creer un environnement sain et equilibre ou ils peuvent s'epanouir. Ci-dessous sont enumeres l'environnement de travail et les exigences pour ce poste :

Capable de communiquer, recevoir et comprendre des informations et des idees avec des groupes diversifies de personnes de maniere comprehensible et raisonnable Capable de travailler debout et immobile pendant les heures de travail habituelles Capable de travailler dans des environnements de travail non traditionnels Capable d'utiliser et d'apprendre a utiliser efficacement des equipements de bureau standard et des technologies Capable de performer avec succes sous pression tout en priorisant et gerant plusieurs projets ou activites Peut etre expose a des elements potentiellement dangereux typiquement trouves dans les environnements de soins de sante ou de laboratoire Ce poste necessite des deplacements independants jusqu'a 80 %, incluant les deplacements en voiture, en avion et en train

Avantages

Nous offrons une remuneration competitive, un plan de bonus incitatif annuel, des soins de sante, ainsi qu'une gamme d'avantages sociaux. Thermo Fisher Scientific propose un emploi au sein d'une organisation innovante et tournee vers l'avenir, offrant d'excellentes perspectives de carriere et de developpement. Nous promouvons une culture d'entreprise passionnante, caracterisee par l'integrite, l'intensite, l'engagement et l'innovation !