Senior Clinical Research Associate
Il y a 5 mois
**Position Summary**:
The Senior CRA has wide-ranging and broad experience and typically handles the most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management.
Incumbents are expected to be able to manage appropriately sized or complex clinical trials and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.
**Essential functions of the job include but are not limited to**:
- Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
- If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
- Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
- Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
- Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
- Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
- Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team.
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools.
- Assists the team managers in the preparation and review of protocols and other study documentation.
- Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).
- Assists with review of clinical study reports.
- Functions as a mentor, assisting with the training and developing of new employees and junior monitors.
- Interacts with client, participates in proposal activities, including development and client presentations.
- Initiates payment requests for investigators.
- Travels as necessary according to project needs.
- Performs other duties as assigned by management.
**Qualifications**:
Minimum Required:
- Europe: University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional.
- N. America: 4-year college degree or equivalent experience in a scientific or healthcare discipline
- 3.5 years or m
-
Senior Clinical Research Associate
il y a 4 semaines
Paris, Île-de-France Parexel Temps pleinUnlock Your Potential in a Dynamic Clinical Research EnvironmentParexel is seeking a talented Senior Clinical Research Associate to support our oncology studies in France. This home-based role offers a unique opportunity to work with industry leaders and subject matter experts, while developing your skills and expertise in clinical trial management.As a...
-
Senior Clinical Research Associate
il y a 4 semaines
Paris, Île-de-France Parexel Temps pleinAbout the RoleParexel is seeking a Senior Clinical Research Associate to join our team in France. As a Senior Clinical Research Associate, you will be responsible for site management and monitoring activities across assigned oncology studies.Key ResponsibilitiesManage and monitor clinical trials in oncologyWork with industry leaders and subject matter...
-
Clinical Research Associate
Il y a 3 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...
-
Senior Clinical Research Associate
il y a 3 semaines
Paris, Île-de-France Allucent Temps pleinJob Title: Sr. Clinical Research AssociateJob Summary: We are seeking a highly experienced Senior Clinical Research Associate to join our team at Allucent. In this role, you will be responsible for independently controlling and monitoring investigational sites, detecting issues proactively, and providing solutions to ensure clinical studies are performed...
-
Senior Clinical Research Associate
il y a 1 jour
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...
-
Senior Clinical Research Associate – Global Clinical Trials
il y a 4 semaines
Paris, Île-de-France Allucent Temps pleinAbout the RoleWe are seeking a highly experienced Senior Clinical Research Associate to join our global clinical trials team at Allucent. As a key member of our team, you will be responsible for monitoring and managing clinical studies to ensure compliance with regulatory requirements and Good Clinical Practice.Key ResponsibilitiesIndependently monitor and...
-
Clinical Research Associate
Il y a 8 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 6 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...
-
Senior Clinical Research Associate
Il y a 5 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 4 semaines
Paris, Île-de-France Parexel Temps pleinAbout this roleParexel is seeking a Clinical Research Associate II in France to work on a home-based position dedicated to a single sponsor. This role offers tremendous long-term job security and prospects.ResponsibilitiesManage site monitoring and activities across assigned oncology studies.Work with industry leaders and subject matter experts.Opportunity...
-
Freelance Clinical Research Associate
il y a 4 semaines
Paris, Ile-de-France Meet Temps pleinJob Title: Freelance Clinical Research Associate (CRA) – Full-Time Location: Remote/France Job Type: Full-Time Freelance (FTE 1.0)Job Description: We are seeking an experienced Freelance Clinical Research Associate (CRA) for full-time engagement to manage oncology-focused clinical trials. This is an opportunity for someone with extensive experience in...
-
Freelance Clinical Research Associate
il y a 4 semaines
Paris, France Meet Temps pleinJob Title: Freelance Clinical Research Associate (CRA) – Full-Time Location: Remote/France Job Type: Full-Time Freelance (FTE 1.0)Job Description: We are seeking an experienced Freelance Clinical Research Associate (CRA) for full-time engagement to manage oncology-focused clinical trials. This is an opportunity for someone with extensive experience in...
-
Clinical Research Associate
Il y a 5 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 Ii
Il y a 6 mois
Paris, France Worldwide Clinical Trials Temps plein**Requisition Number** **6653** **Employment Type***: **Regular** **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...
-
Senior Clinical Research Associate
il y a 4 semaines
Paris, Île-de-France Allucent Temps pleinAt Allucent, we are dedicated to supporting the success of small to medium-sized biopharmaceutical companies in navigating the complex landscape of clinical trials.We are seeking a highly experienced Senior Clinical Research Associate (CRA) to join our team. As a Senior CRA at Allucent, you will be responsible for independently monitoring and controlling...
-
Senior Clinical Research Associate Ii
il y a 1 mois
Paris, France Caidya Temps plein**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. -...
-
Clinical Research Associate
il y a 4 semaines
Paris, Île-de-France Meet Temps pleinJob Title: Freelance Clinical Research Associate (CRA)Location: RemoteJob Type: Freelance Full-TimeJob Description:Meet is seeking an experienced Freelance Clinical Research Associate (CRA) to manage oncology-focused clinical trials. The ideal candidate is passionate about advancing medical knowledge and excels in a fast-paced, detail-oriented work...
-
Clinical Research Associate II
il y a 1 mois
Paris, Île-de-France Parexel Temps pleinUnlock Your Potential in Clinical ResearchParexel is seeking a Clinical Research Associate II to join our team in France. This home-based position will be dedicated to a single sponsor, allowing for a high level of focus and expertise.As a Clinical Research Associate II, you will be responsible for all site management and monitoring activities across...
-
Senior Clinical Research Associate
Il y a 5 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 Ii
Il y a 7 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...
