Senior Clinical Research Associate Ii
Il y a 2 mois
**Job Title**:Senior Clinical Research Associate II**
**Job Location**: France (Home-based position, any location in France considered)**Job Overview**:
**Job Duties and Responsibilities**:
- Provides support to Project Team and Clinical Operations Team.
- Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.
- Demonstrates strong written and verbal communication skills.
- Serves as primary contact for assigned research sites.
- Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
- Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
- Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
- Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
- Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
- May support translations of essential documents.
- May support submission of trials to IRB/IEC and regulatory authorities.
- Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
- Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
- Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
- Ensures that sites have sufficient project specific supplies.
- Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.
- Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
- Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
- Participates in site audits, as requested.
- May conduct site and study feasibility assessments.
- Provides input into study documentation and monitoring worksheets.
- Uphold the confidentiality agreements with all clients and colleagues outside Caidya Clinical Research.
- Pays attention to signals of fraud, misconduct and escalates per Caidya SOP.
- Work according to the Caidya Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
- Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the Caidya time allocation system.
- May perform Trip Report review, management, resolution and escalation.
- May conduct project co-monitoring visits
- May conduct project team training.
- May conduct Team calls and Sponsor calls (as needed).
- May provide project-specific performance feedback.
- May manage Protocol Deviation documentation, tracking, and escalation.
- May relate project status and issues to Project Manager and/or CRAs.
- May serve as Sponsor contact for monitoring/site issues.
- May assist the Project Manager with coordination and management of the project budget, grant administration and project invoicing.
- Attends and participates in team teleconferences/meetings providing mentoring and training.
- Participates in relevant trial meetings, e.g. Kick-off, Investigator, and Monitor meetings, and provides support, as requested.
- Demonstrates flexibility and adaptability.
- Assists project team in development of monitoring guidelines and tools.
- Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
- Provides support to Project Team.
- May conduct SOV and QAV assessments
- Provides mentorship, training and direction to Clinical Research Associates when needed.
- Other duties as assigned by Clinical Operations Manager/Project Manager and per project-specific requirements.
- May participate in delivering Clinical Monitoring portion of a bid defense presentation.
**Supervisory Responsibilities**:
No supervisory responsibilities.
**Job Requirements**:
- Education
- 4-year college graduate, preferably with a healthcare or life science degree.
- Experience
- Minimum of 6 years of experience in on-site monitoring of clinical studies
- Monitoring experience in complex therapeutic indications, across multiple therapeutic areas.
- Experience in all areas of monitoring (on-site, remote, etc.)
- Skills/Com
-
Clinical Research Associate Ii
Il y a 9 mois
Paris, France ICON Temps plein**As a Clinical Research Associate** you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs. **We are...
-
Clinical Research Associate
Il y a 4 mois
Paris, France Translational Research in Oncology Temps pleinIf you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is...
-
Clinical Research Associate I/ii
il y a 6 jours
Paris, France PSI CRO Temps pleinCompany Description PSI is a leading Contract Research Organization with more than 22 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: As a Clinical Research Associate at PSI...
-
Clinical Research Associate I/ii
il y a 1 semaine
Paris, France PSI CRO Temps pleinCompany Description PSI is a leading Contract Research Organization with more than 22 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: As a Clinical Research Associate at PSI...
-
Senior Clinical Research Associate
Il y a 7 mois
Paris, France ICON Temps pleinWe are looking for motivated, reliable, and dedicated CRAs with at least 3 years of independent external monitoring of commercial studies. Experience in Diabetes/Obesity, Cardiovascular, Chronic Disease, or Rare Diseases, especially in phases I-II-III, is an asset. As a Clinical Research Associate, you will be dedicated to our global pharmaceutical...
-
Senior Clinical Research Associate
il y a 1 mois
Paris, France Parexel Temps pleinParexel is currently seeking Senior Clinical Research Associates in France with oncology experience. Working as a Senior Clinical Research Associate at Parexel offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of...
-
Clinical Research Associate Ii
Il y a 7 mois
Paris, France Sitero LLC Temps pleinSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our...
-
Clinical Research Associate
Il y a 9 mois
Paris, France VCLS Temps plein**Clinical Research Associate** VCLS is seeking a highly motivated, curious and detail-oriented Clinical Research Associate (CRA) to join our team. As a CRA, you will be responsible for monitoring and managing clinical trial activities to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will...
-
Contract Senior Clinical Research Associate
Il y a 7 mois
Paris, France Ora Temps plein**POSITION TITLE**: Senior Clinical Research Associate **DEPARTMENT**:Ora Europe **LOCATION**: Remote, France **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug...
-
Clinical Research Associate
il y a 1 semaine
Paris, France Worldwide Clinical Trials Temps plein**Requisition Number** **5535** **Employment Type***: **Contractor** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
-
Clinical Research Associate Ii
il y a 1 mois
Paris, France Caidya Temps plein**Job Title**:Clinical Research Associate II**Job Location**:Paris - France (Home based - any location in France considered)Caidya has an exciting opportunity for a CRA with experience in monitoring early phase oncology projects to join our growing team in France! **Job Overview**: **Job Duties and Responsibilities**: - Provides support to Project Team and...
-
Clinical Research Associate
Il y a 7 mois
Paris, France ICON plc Temps plein**We are currently looking for an experienced Clinical Research Associate to join one of our sponsor-dedicated team in Courbevoice (1-2 days office based).** Key responsibilities include: - Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out - Planning and...
-
Clinical Research Associate
Il y a 7 mois
Paris, France Institut de Myologie Temps pleinLocated in Paris at the heart of Europe’s largest hospital, the Pitié-Salpêtrière, the Institute of Myology was created in 1996 under the impetus of an association of patients and parents of patients, the AFM-Telethon. Its objective is to promote the existence, recognition and development of myology as a clinical and scientific discipline in its own...
-
Senior Clinical Research Associate
Il y a 7 mois
Paris, France TFS HealthScience Temps pleinTFS HealthScience is excited to be expanding our** **team and we are looking for an experienced, highly motivated **Clinical Research Associate** who shares our vision of providing clinical research excellence. Our CDS team is a highly experienced international group of professionals led by an industry expert. We are a leading global mid-size Contract...
-
Clinical Research Associate
Il y a 7 mois
Paris, France Icon plc Temps pleinICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical and biotechnology organisations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and...
-
Clinical Research Associate 2
Il y a 7 mois
Paris, France Veranex, Inc. Temps pleinVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Clinical Research Associate
Il y a 7 mois
Paris, France ICON plc Temps plein**We are currently looking for an experienced Clinical Research Associate to join one of our sponsor-dedicated team in Courbevoice (1-2 days office based).** Key responsibilities include: - Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out - Planning and...
-
Senior Clinical Research Associate
Il y a 3 mois
Paris, France orano Temps pleinLe Senior Clinical Research Associate supervisera les activités cliniques externalisées, incluanT la gestion et la surveillance des sites, ainsi que le classement des documents TMF (Trial Master File) au niveau des sites. Des responsabilités supplémentaires peuvent être assignées, comme la gestion des laboratoires centraux. Missions et...
-
Clinical Research Associate
il y a 4 semaines
Paris, France Scope International France Temps pleinPrise de poste : 03/03/2025 BAC +5 Paris Nombre de poste : 1 CDI Rémunération non définie **Description du poste et des missions**: **SCOPE International** is an independent Full-Service Contract Research Organization (CRO) with a network of 15 local offices and business entities throughout Europe and USA. SCOPE offers a complete range of clinical...
-
Clinical Research Associate
Il y a 7 mois
Paris, France Worldwide Clinical Trials Temps plein**Requisition Number** **6980** **Employment Type***: **Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our...
