Clinical Research Associate I/II

Work Schedule

Environmental Conditions

Job Description

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 youll 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

• Bachelors 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 drivers 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 potentialinvestigators in collaboration with the client company to ensure the acceptabilityof qualified investigative sites. Initiates clinical trial sites according to therelevant procedures to ensure compliance with the protocol and regulatory andICH GCP obligations making recommendations where warranted. Performs trialclose out and retrieval of trial materials.
Ensures that required essential documents are complete and in place accordingto ICH-GCP and applicable regulations. Conducts on-site file reviews as perproject specifications.
Provides trial status tracking and progress update reports to the Clinical TeamManager (CTM) as required. Ensures study systems are updated per agreedstudy conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites the clientcompany and the PPD project team through written oral and/or electroniccontacts.

Responds to company client and applicable regulatoryrequirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports andtimesheets in a timely manner.
Contributes to the project team by assisting in preparation of projectpublications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement asrequired.

Dtails du poste:

Poste: CRA Niveau I/II

Lieu: Canada Toronto- distance

Exprience requise:

• Exprience antrieure en surveillance clinique; sur place ou distance (OBLIGATOIRE)
• Dplacements: jusqu 80% (OBLIGATOIRE)

Chez Thermo Fisher Scientific vous dcouvrirez un travail significatif ayant un impact positif lchelle mondiale. Rejoignez nos collgues pour donner vie notre mission - permettre nos clients de rendre le monde plus sain plus propre et plus sr. Nous fournissons nos quipes les ressources ncessaires pour atteindre leurs objectifs de carrire individuelle tout en faisant progresser la science par la recherche le dveloppement et la livraison de thrapies rvolutionnaires. Avec des essais cliniques mens dans plus de 100 pays et le dveloppement continu de nouveaux cadres pour la recherche clinique travers notre portefeuille de recherche clinique PPD notre travail couvre les services de laboratoire dessais cliniques numriques et dcentraliss. Votre dtermination fournir qualit et prcision amliorera les rsultats de sant dont dpendent les personnes et les communauts - maintenant et lavenir.

Informations spcifiques sur le lieu / division

Nos collgues mondiaux des Oprations Cliniques au sein de nos services de recherche clinique PPD fournissent un support complet pour les essais cliniques depuis le dmarrage de ltude jusqu la surveillance et la clture de ltude sur des contrats commerciaux et gouvernementaux. Ensemble nous aidons les clients dfinir et dvelopper des programmes cliniques minimiser les retards et excuter des tudes cliniques de haute qualit et rentables.

Dcouvrez un Travail Impactant :

Ralise et coordonne tous les aspects du processus de surveillance clinique et de gestion de site. Effectue des visites distance ou sur site pour valuer la conformit aux protocoles et aux rglementations et gre la documentation requise. Gre les procdures et les lignes directrices provenant de diffrents sponsors et / ou environnements de surveillance (cest--dire FSO FSP gouvernement etc.). Agit en tant que spcialiste des processus de site en sassurant que lessai est conduit conformment au protocole approuv aux lignes directrices ICH-GCP aux rglementations applicables et aux SOP pour garantir les droits le bien-tre des sujets et la fiabilit des donnes. Assure la prparation aux audits. Dveloppe des relations collaboratives avec les sites dinvestigation. Les tches et responsabilits dtailles assignes ce rle sont dcrites dans la matrice des tches.

Une journe type :

• Surveille les sites des investigateurs avec une approche de surveillance base sur les risques : applique lanalyse des causes profondes (RCA) la pense critique et les comptences en rsolution de problmes pour identifier les dfaillances des processus du site et les actions correctives / prventives pour assurer la conformit du site et rduire les risques. Assure lexactitude des donnes grce lexamen des SDR SDV et CRF selon les activits de surveillance sur site et distance
• value le produit dinvestigation par linventaire physique et lexamen des dossiers
• Documente les observations dans des rapports et lettres en utilisant des normes dcriture commerciale approuves et dans les dlais impartis. Signale rapidement les dficiences et problmes observs la direction clinique et suit toutes les issues jusqu leur rsolution
• Peut maintenir un contact rgulier entre les visites de surveillance avec les sites dinvestigation pour confirmer que le protocole est suivi que les problmes identifis prcdemment sont rsolus et que les donnes sont enregistres en temps voulu. Effectue les tches de surveillance conformment au plan de surveillance approuv. Participe au processus de paiement des investigateurs. Assume une responsabilit partage avec les autres membres de lquipe projet pour la rsolution des problmes et des constatations. Enqute et suit les constatations le cas chant
• Participe aux runions des investigateurs selon les besoins. Peut aider identifier les investigateurs potentiels en collaboration avec lentreprise cliente pour assurer lacceptabilit des sites dinvestigation qualifis. Initie les sites dessais cliniques selon les procdures pertinentes pour assurer la conformit avec le protocole les obligations rglementaires et ICH GCP en faisant des recommandations lorsque ncessaire. Effectue la clture de lessai et la rcupration des documents dessai
• Sassure que les documents essentiels requis sont complets et en place conformment ICH-GCP et aux rglementations applicables. Effectue des revues de dossiers sur site selon les spcifications du projet
• Fournit un suivi de ltat de lessai et des rapports de progression lquipe selon les besoins. Sassure que les systmes dtude sont complets exacts et mis jour selon les conventions dtude convenues (par ex. Systme de gestion des essais cliniques)
• Facilite la communication efficace entre les sites dinvestigation lentreprise cliente et les quipes de projet internes par contacts crits oraux et / ou lectroniques. Rpond aux exigences / audits / inspections de lentreprise du client et des rglementations applicables
• Maintient et complte les tches administratives telles que les rapports de dpenses et les feuilles de temps en temps opportun
• Contribue lquipe projet en aidant la prparation des publications / outils du projet et en partageant des ides / suggestions avec les membres de lquipe. Contribue dautres travaux de projet et initiatives damlioration des processus selon les besoins

Cls du succs :

ducation

• Diplme de baccalaurat dans un domaine des sciences de la vie ou certification en soins infirmiers enregistre ou quivalent ainsi quune qualification acadmique / vocationnelle formelle pertinente

Exprience

• Exprience minimale de surveillance clinique fournissant les connaissances comptences et capacits pour effectuer le travail (comparable 2 ans) dans un environnement clinique o lexprience est acquise dans les essais cliniques la terminologie mdicale la recherche mdicale la recherche clinique ou les sciences de la sant ou exprience dans un domaine des sciences de la sant avec une formation formelle en terminologie mdicale et en anatomie
• Permis de conduire valide

Dans certains cas une quivalence consistant en une combinaison de formations et / ou dexpriences directement lies sera considre comme suffisante pour quun individu rponde aux exigences du poste.

Connaissances comptences capacits

• Connaissance de base des domaines mdicaux / thrapeutiques et comprhension de la terminologie mdicale
• Capacit acqurir et maintenir une connaissance pratique des ICH GCP et des rglementations applicables ainsi que des documents procduraux
• Bonnes comptences en communication orale et crite avec la capacit de communiquer efficacement avec le personnel mdical
• Bonnes comptences interpersonnelles
• Capacit maintenir lattention sur le client en utilisant de bonnes comptences dcoute une attention aux dtails et la capacit de percevoir les problmes sous-jacents des clients
• Bonnes comptences en organisation et gestion du temps
• Capacit rester flexible et adaptable dans une large gamme de scnarios
• Comptences dveloppes en pense critique y compris mais sans sy limiter : esprit critique investigation approfondie pour une analyse approprie des causes profondes et rsolution de problmes
• Capacit grer les concepts et processus de surveillance bases sur les risques
• Capacit travailler en quipe ou de manire indpendante selon les besoins
• Bonnes comptences informatiques : solide connaissance de Microsoft Office et capacit apprendre utiliser les logiciels appropris
• Bonnes comptences en anglais et en grammaire

Environnement de travail

Thermo Fisher Scientific valorise la sant et le bien-tre de ses employs. Nous encourageons et soutenons les individus crer un environnement sain et quilibr o ils peuvent spanouir. Ci-dessous sont numrs lenvironnement de travail et les exigences pour ce poste :

• Capable de communiquer recevoir et comprendre des informations et des ides avec des groupes diversifis de personnes de manire comprhensible 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 dutiliser et dapprendre utiliser efficacement des quipements de bureau standard et des technologies
• Capable de performer avec succs sous pression tout en priorisant et grant plusieurs projets ou activits
• Peut tre expos des lments potentiellement dangereux typiquement trouvs dans les environnements de soins de sant ou de laboratoire
• Ce poste ncessite des dplacements indpendants jusqu 80 % incluant les dplacements en voiture en avion et en train

Avantages

Nous offrons une rmunration comptitive un plan de bonus incitatif annuel des soins de sant ainsi quune gamme davantages sociaux. Thermo Fisher Scientific propose un emploi au sein dune organisation innovante et tourne vers lavenir offrant dexcellentes perspectives de carrire et de dveloppement. Nous promouvons une culture dentreprise passionnante caractrise par lintgrit lintensit lengagement et linnovation !