Lead Clinical Research Associate
hace 1 mes
**POSITION TITLE**: Lead Clinical Research Associate
**DEPARTMENT**: Ora Europe
**LOCATIONS**:Remote, Spain
**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 and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.** **Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
**The Role**:
Ora's Lead Clinical Research Associate (Lead CRA) develops strong clinical site relationships and are accountable for hands-on delivery of project tasks in addition to delegation and oversight of more junior CRA's project tasks, providing advice and guidance to help achieve high performance and quality project deliverables. Our Lead CRA's will work independently and partner with the CRA line Manager to ensure Ora's compliance with study conduct by monitoring the site activities regarding ICH/GCP and country regulations, Ora's policies, and Standard Operating Procedures (SOPs) and sponsor requirements. The Lead CRA will work in collaboration with Ora's Quality Assurance and Regulatory teams in addition to the external sponsors and sites through all phases of the trial.
**What You'll Do**:
- Independently customize and maintain the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
- Ensure overall project efficiency and adherence to project timelines; report metrics and out-of-scope activities to the CRA line Manager, Sponsors, or Clinical PM's.
- Collaborate with other functional groups within the company such as data management, project management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to the assigned clinical project management leaders.
- Conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively escalate quality or non-compliance issues to Monitoring Management.
- Handle escalations for site management questions and issues for assigned projects.
- Develop and deliver presentations & training to clients, colleagues and professionals, as required.
- May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
- Host routine CRA team calls with a focus on best practice / knowledge sharing.
- Provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable.
- Supports audit and inspection activities as needed and may assist with on-site CRA training and evaluation upon request.
- Travel Requirements up to 25%.
- Adhere to all aspects of Ora's quality system.
- Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values
- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
- Responsibilities may differ from the above based on the specific needs of the business.
**What We Look For**:
- _Experience needed for the Role:_
- Bachelor's degree with 5 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education
- Prior team and/or site lead experience
- _Additional Skills & Attributes:_
- Ophthalmic experience strongly preferred.
- Understand how to properly assess an investigative site's capabilities for conducting clinical research.
- Ability to monitor and report on the progress of the trial from start-up to completion. Knowledge of how to select and qualify an investigative site.
- Strong attention to detail in order to review CRA visit reports.
- Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits.
- Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Multilingual communication is a plus
- _Competencies and Personal Traits:_
- **What We Do**:
- **Execution Excellence**:Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
- **How We Do I
-
Clinical Research Lead
hace 2 semanas
Madrid, Madrid, España Ora A tiempo completoAbout OraOra is a leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to bring new products and therapies to market. With over 45 years of experience, our expert teams have helped earn more than 85 new product approvals.The Role: Lead Clinical Research AssociateAs a Lead Clinical Research...
-
Clinical Research Associate
hace 7 meses
Madrid, España TFS HealthScience A tiempo completoOverview: CLINICAL RESEARCH ASSOCIATE MADRID - SINGLE SPONSOR TFS HealthScience is excited to be expanding our SRS** **team and we are looking for an experienced, highly motivated regional Senior Clinical Research Associate (CRA) who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of...
-
Senior Clinical Research Associate
hace 2 días
Madrid, España Premier Research A tiempo completoPremier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. We’re looking for an exceptional **Clinical Research Associate II / Senior CRA** to bring your passion to our team. You will be encouraged to...
-
Senior Clinical Research Associate
hace 2 días
Madrid, España Premier Research A tiempo completoPremier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. We’re looking for an exceptional **Clinical Research Associate II / Senior CRA** to bring your passion to our team. You will be encouraged to...
-
Senior Clinical Research Associate
hace 6 meses
Madrid, España Worldwide Clinical Trials A tiempo completo**Requisition Number**7739** **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 company’s...
-
Senior Clinical Research Associate
hace 7 meses
Madrid, España Worldwide Clinical Trials A tiempo completo**Requisition Number** **7313** **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...
-
Clinical Research Associate
hace 7 meses
Madrid, España TFS HealthScience A tiempo completoOverview: **Clinical Research Associate Madrid** TFS HealthScience is excited to be expanding our SRS** **team and we are looking for an experienced, highly motivated regional Senior Clinical Research Associate (CRA) who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of professionals...
-
Clinical Research Associate Lead
hace 2 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoAbout Syneos HealthSyneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We deliver innovative, tailored solutions that bring unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Job DescriptionAs a Senior Clinical Research...
-
Clinical Research Associate
hace 8 meses
Madrid, España EastHORN Clinical Services A tiempo completo**Job summary**: As an Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties. You...
-
Clinical Research Associate
hace 6 días
Madrid, España EastHORN Clinical Services A tiempo completoAs an experienced **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties. You...
-
Global Clinical Research Associate
hace 4 semanas
Madrid, Madrid, España Engineeringuk A tiempo completoJob OverviewAs a Global Clinical Research Associate at Engineeringuk, you will be part of the world's largest and most comprehensive clinical research organisation, driven by healthcare intelligence.About the RoleThe Clinical Research Associate is a field-based expert who supports the conduct and patient recruitment of client global clinical trials at...
-
Clinical Research Associate
hace 3 meses
Madrid, España Boston Scientific Corporation A tiempo completo**Job Description**: **Posted Date**: - Sep 26, 2024**Workmode**: - Hybrid**Additional Locations**: Spain-Madrid; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; United Kingdom-Hemel Hempstead **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give...
-
Clinical Research Project Lead
hace 3 semanas
Madrid, Madrid, España Icon Clinical Plc A tiempo completoRole OverviewWe are seeking an experienced Clinical Research Project Lead to join our team in ICON plc, a world-leading healthcare intelligence and clinical research organization.
-
Clinical Research Associate
hace 2 días
Madrid, España Premier Research A tiempo completoPremier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. Working at Premier Research means being an individual - you will be recognized...
-
Clinical Research Associate
hace 1 mes
Madrid, España Tfs Healthscience A tiempo completo.TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Clinical Research Associate (CRA) About...
-
Clinical Research Associate
hace 7 meses
Madrid, España Thermo Fisher Scientific A tiempo completoClinical Research Associate I/II - Madrid or Barcelona 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...
-
Clinical Research Associate
hace 7 meses
Madrid, España Novo Nordisk A tiempo completoClinical Research Associate **Category**:Clinical Development**Location**:Madrid, Comunidad de Madrid, ES- Are you a dedicated clinical trial professional with solid site management experience? Are you highly motivated by being able to make a difference to improving patients’ lives? If yes, keep reading - this role might be just for you!**The position** -...
-
Clinical Research Associate II
hace 3 semanas
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoAccelerate the Delivery of TherapiesSyneos Health, a leading biopharmaceutical solutions organization, is seeking a Clinical Research Associate II to join our team. $85,000 - $110,000 per year, depending on location and experience.Company OverviewWe translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities....
-
Clinical Research Associate
hace 3 semanas
Madrid, España TFS HealthScience A tiempo completoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a Clinical Research Associate (CRA)About...
-
Clinical Research Associate
hace 3 semanas
Madrid, España Thermo Fisher Scientific A tiempo completo.Job Description Clinical Research Associate I/II - Barcelona 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...
