Clinical Research Associate

il y a 3 semaines

MontbonnotSaintMartin, France Corin Group Temps plein

Join Corin to work within a small dynamic team that has a high impact on the quality of life of patients worldwide We are not a start-up business; we have market-leading products which are being further developed for the global orthopaedic market. The primary focus of the Clinical Research Associate (CRA) is to manage assigned clinical studies in compliance with protocols, company SOPs and applicable regulations on medical devices. The CRA is involved in all stages of the clinical study, including assisting with identifying and assessing investigational sites and investigators and setting up, initiating, monitoring and closing the study.

Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. We offer a unique combination of clinically proven hip & knee solutions and world leading technologies. Our OMNIBotics & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.

The key responsibilities for the Clinical Research Associate are to:

- Contribute to the development of clinical study protocols, case report forms (CRFs) and other study materials
- Assist in identifying and to assess the suitability of facilities to use as the clinical study site
- Assist in identifying/selecting an investigator who will be responsible for conducting the study at the local study site
- Liaise with investigators and site research teams to prepare the necessary documentation for the Ethics Committee (EC) and to manage any EC questions
- Coordinate the execution of study agreements
- Set up the study sites - ensuring each site has the study materials and conduct site initiation visit and site staff study-specific training
- Develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and compliance in accordance with the protocol
- Identify, evaluate, report and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations
- Prepare and conduct on-site study monitoring visits throughout its duration verifying that data entered on to the CRFs is consistent with patient clinical notes
- Coordinate the collection of completed CRFs from study sites
- Write high quality and accurate visit reports and follow -up with sites on outstanding items Perform the close-out activities on completion of the study
- Maintain and file study documentation in an organised manner and archive following study closure
- Prepare data for final analysis and contribute to final study summary report as requested
- Assist in the preparation and/or review of conference abstracts, manuscripts for the assigned studies
- Monitor the costs of the assigned studies to be in line with the agreed budget and escalate where differences are identified
- Provide data summary and updates of the assigned studies for the internal Product Annual Post Market Surveillance (PMS) Meetings
- Participate in the review of departmental operating procedures
- Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820
- Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives for CAPA

**The ideal Clinical Research Associate will have**:

- Previous clinical research experience (min 3 years) with a healthcare company or Clinical Research Organisation (CRO). Experience in a medical device company is preferred
- Advanced knowledge and experience with GCP/ICH, ISO 14155:2020
- Advanced Knowledge of medical device regulation (MDR) and local requirement
- Good computer skills: good knowledge of Microsoft Office including MS Outlook, Word, Excel and Power Point
- Basic statistical analysis
- High attention to detail
- Good English speaking and written skills including writing clinical documents in English
- Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
- Effective interpersonal skills with ability to work in a team or independently as required
- Ability to multi-task and manage priorities with effective organisational and time management skills
- Demonstrated flexibility and adaptability
- Highly motivated with a proactive approach to learning and problem solving
- Ability to travel up to 30%, depending on the stage and needs of the clinical study.

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran s

  • Clinical Research Nurse

    il y a 2 semaines

    Saint-Étienne, France Barrington James Temps plein

    I am seeking a highly motivated and experienced Freelance Clinical Research Nurse to join an exciting new project! If you have a strong background in study coordination and patient care, this opportunity could be perfect for you!Key Responsibilities:Support patient recruitment at the study center and schedule patient appointments.Maintain pre-screening lists...

  • Clinical Research Nurse

    il y a 2 semaines

    Saint-Étienne, France Barrington James Temps plein

    I am seeking a highly motivated and experienced Freelance Clinical Research Nurse to join an exciting new project! If you have a strong background in study coordination and patient care, this opportunity could be perfect for you! Key Responsibilities: Support patient recruitment at the study center and schedule patient appointments. Maintain...

  • Clinical Research Nurse

    il y a 4 jours

    Saint-Étienne, France Barrington James Temps plein

    I am seeking a highly motivated and experienced Freelance Clinical Research Nurse to join an exciting new project! If you have a strong background in study coordination and patient care, this opportunity could be perfect for you! Key Responsibilities: Support patient recruitment at the study center and schedule patient appointments. Maintain...

  • Phd - Research Engineer Associate W/m

    Il y a 7 mois

    Montbonnot-Saint-Martin, France Siemens Digital Industries Software Temps plein

    **Siemens Digital Industries - Where today meets tomorrow.** **Let's make the difference together!** Siemens EDA is a global technology leader in Electronic Design Automation software. Our software tools enable companies around the world to develop new and highly innovative electronic products faster and more cost-effectively. Our customers use our tools...

  • Field Clinical Specialist-crm

    Il y a 7 mois

    Saint-Quentin-en-Yvelines, France Boston Scientific Corporation Temps plein

    **Field Clinical Specialist-CRM**: - Remote Eligible: Field Based- Territory: **Additional Location(s)**: France-Auvergne-Rhône-Alpes **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and...

  • [trainee] - Deep Learning for Infant Motion

    Il y a 7 mois

    Montbonnot-Saint-Martin, France Inria Temps plein

    Le descriptif de l’offre ci-dessous est en Anglais_ **Niveau de diplôme exigé **:Bac + 3 ou équivalent**Fonction **:Stagiaire de la rechercheA propos du centre ou de la direction fonctionnelle Grenoble Rhône-Alpes Research Center groups together a few less than 800 people in 39 research teams and 8 research support departments. Staff is localized on...

  • Intership Scalable Unsupervised Subtle Anomaly

    Il y a 2 mois

    Montbonnot-Saint-Martin, France Inria Temps plein

    Le descriptif de l’offre ci-dessous est en Anglais_ **Niveau de diplôme exigé **:Bac + 5 ou équivalent **Fonction **:Stagiaire de la recherche **Niveau d'expérience souhaité **:Jeune diplômé **A propos du centre ou de la direction fonctionnelle**: The Centre Inria de l’Université de Grenoble groups together almost 600 people in 22 research...

  • Field Clinical Specialist- Electrophysiologie Ep

    Il y a 7 mois

    Saint-Quentin-en-Yvelines, France Boston Scientific Corporation Temps plein

    **Work mode**:Remote in Country**Onsite Location(s)**:Saint Quentin en Yvelines, FR**Additional Location(s)**: France-Normandie**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and...

  • Night Duty Registered Nurse

    il y a 2 semaines

    Saint-Étienne, France Barrington James Temps plein

    I am seeking a highly motivated and experienced Freelance Clinical Research Nurse to join an exciting new project! Document patient data. Ensure data quality in documentation sheets, source data, and (e)CRFs in collaboration with physicians and study personnel.

  • Legal Associate

    Il y a 2 mois

    Plaines-Saint-Lange, France Kalexius Temps plein

    As a major player in the legal outsourcing services market for 12 years, Kalexius is committed to delivering excellence to law firms and corporate legal departments across the globe. Kalexius is an international company implanted in 7 countries and is recognized in its field by Chambers & Partners. What sets Kalexius apart is its caring working environment...

  • Compliance Manager France

    il y a 3 semaines

    Montbonnot-Saint-Martin, France CORIN FRANCE Temps plein

    Open position: M/F Type of contract: permanent contract Full-time Starting date: Immediate Place of work: Grenoble region **Compliance Manager France** **Position Context**: The Compliance Manager France will report and work closely with the Head of Compliance Europe. The Compliance Manager France will be in contact and work with the following services:...

  • Compliance Manager France

    il y a 3 semaines

    Montbonnot-Saint-Martin, France Corin Group Temps plein

    Compliance Manager France will report and work closely with the Head of Compliance Europe. Corin is a medical device business that distributes hip and knee implants and associated technologies worldwide. Connect your ambition with our vision, our people and product's change peoples lives. The Compliance Manager France will be in contact and work with the...

  • Bio-informaticien(Enne) Omics

    il y a 3 semaines

    Saint-Priest, France LGD France Temps plein

    LGD SARL is a pharmaceutical research and development business, that conducts in vitro, preclinical, and clinical investigations with the goal of creating novel therapeutic approaches for the prevention and treatment of age-related pathologies. LGD SARL is a young biotech, created in 2020. Its corporate offices are in Velaux (Bouches-du-Rhône) and its R&D...

  • Clinical Data Manager

    Il y a 7 mois

    Saint-Vulbas, France BI AH France SCS Temps plein

    Sous la supervision mínimale et conformément aux échéanciers spécifiques au projet, effectuer des activités simples de gestion des données pour garantir la génération de bases de données cliniques, précises, complètes et cohérentes. Ce poste servira également en tant que ressource aux Associés de Saisie de Données (Data Entry Associates)...

  • Assistant Ressources Humaines

    Il y a 7 mois

    Saint-Germain-Nuelles, France Charles River Laboratories Temps plein

    **Req ID #**:222303**Location**:Saint Germain Nuelles, FR, 69210- For nearly 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is...

  • Plasma Protein Workflow Advisor and Exent Product

    Il y a 3 mois

    38522 Saint-Égrève, France Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Welcome to Thermo Fisher Scientific Inc.! We are currently seeking an ambitious and dedicated individual for a new role as Workflow advisor & EXENT Product Manager. This is a unique opportunity to join a fantastic Marketing team and contribute to the success of our world-class...

  • Tax Director- Bellevue

    il y a 1 semaine

    Saint-Nazaire, France Fair, Anderson & Langerman Temps plein

    BPM – Assurance Manager Location: Bellevue, WA Tax – Private Client Services (PCS) / Full-time / Hybrid BPM – where caring and community is in our company DNA; we are always striving to be our best selves; and we’re compelled to ask the questions that lead to innovation. As an Assurance Manager, you will be responsible for reviewing, analyzing, and...

  • Innovation Intern

    Il y a 7 mois

    Saint-Cloud, France Kyriba Temps plein

    It's fun to work in a company where people truly BELIEVE in what they're doing! - We're committed to bringing passion and customer focus to the business._ About Kyriba Job Summary: As the Innovation Associate, you will work closely with the innovation team to support the ideation, development, and implementation of new ways of working and processes within...

  • Phd Position

    il y a 4 semaines

    Saint-Étienne, France Institut Mines-Télécom Temps plein

    **JOB ENVIRONMENT**: - Institut Mines-Télécom_ is the leading public group of engineering and management _Grandes Écoles_ in France. Consisting of eight public graduate _Grandes Écoles_ and two subsidiary graduate schools, _Institut Mines-Télécom_ leads and develops a rich ecosystem of partner schools, economic, academic and institutional partners,...