Clinical Research Associate Ii

hace 2 semanas

Barcelona, España Ora A tiempo completo

**POSITION TITLE**: Clinical Research Associate II

**DEPARTMENT**:Ora Europe

**LOCATION**: 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 forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

**The Role**:
Ora's Clinical Research Associate II (CRA II) develops strong clinical site relationships and is accountable for performance and compliance with assigned protocols at our sites. Our CRA II's will work with the oversight of the Lead CRA's and Line Manager. As a CRA II, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross-functionally within Ora.

**What You'll Do**:

- Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain in-depth understanding of the study protocol and related procedures.
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
- Participate & provide input on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities using various tools to ensure:

- Data generated at site are complete, accurate and unbiased.
- Subjects' right, safety and well-being are protected.
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Travel Requirements up to 75%.
- Responsibilities may differ slightly from the above based on specific needs of the business.

**What We Look For**:

- _Experience needed for the Role: _
- Bachelor's degree with 2 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.
- _Additional Skills & Attributes:_
- Ophthalmic experience is strongly preferred.
- Capacity to routinely assess protocol and GCP compliance.
- Demonstrated ability to verify source data to reported data.
- Strong attention to detail to review the completeness of the investigator site file. Knowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits.
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol.
- Proficiency with Excel, CTMS, and EDC.
- Multilingual communication is a plus.
- _Competencies and Personal Traits:_
- **Attention to Detail**: Ability to analyze data to drive successful solutions to complex problems.
- **Emotionally Intelligent Leadership**: Ability to lead with a positive mindset and empathy.
- **Intellectual **Curiosity**: Willingness and desire to learn new things and dig deeper than the surface.
- **Innovative Mindset**: Forward thinking, creative and open to testing, making mistakes and trying again.
- **Organization and Goal Setting**:Ability to set goals, develop structure and maintain a focused approach to critical path work.
- **Resolve Conflicts**:Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
- **Seek Mean

  • Clinical Research Associate

    hace 3 semanas

    Barcelona, España TFS HealthScience A tiempo completo

    Overview: CLINICAL RESEARCH ASSOCIATE CATALUÑA - 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...

  • Clinical Research Associate

    hace 2 semanas

    Barcelona, España TFS HealthScience A tiempo completo

    Overview: CLINICAL RESEARCH ASSOCIATE CATALUÑA - 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...

  • Senior Clinical Research Associate

    hace 2 meses

    Barcelona, España Labcorp A tiempo completo

    **Labcorp Drug Development is currently recruiting for a Senior CRA in Barcelona to work on therapeutic areas Oncology.**: **This particular role is a client dedicated one where you will work exclusively on one sponsor’s trials and SOPs; a client that values their staff and puts an emphasis on career development.**: **What makes this opportunity...

  • Senior Clinical Research Associate

    hace 2 semanas

    Barcelona, España Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **6654** **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

    hace 4 semanas

    Barcelona, España Jr Spain A tiempo completo

    col-wideJob Description:**Labcorp Drug Development is currently recruiting for a Senior CRA in Barcelona to work on therapeutic areas Oncology.**:**This particular role is a client dedicated one where you will work exclusively on one sponsor's trials and SOPs; a client that values their staff and puts an emphasis on career development.**:**What makes this...

  • Senior Clinical Research Associate

    hace 1 mes

    Barcelona, España Worldwide Clinical Trials A tiempo completo

    Requisition Number : 7739 Position Title : Senior Clinical Research Associate External Description : 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...

  • Study Start Up Associate II

    hace 2 días

    Barcelona, Barcelona, España ICON Clinical Research A tiempo completo

    Study Start Up Associate IIAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability &...

  • Study Start Up Associate II

    hace 5 días

    Barcelona, Barcelona, España ICON Clinical Research A tiempo completo

    Study Start Up Associate IIAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability &...

  • Clinical Research Associate

    hace 7 días

    Barcelona, España TFS HealthScience A tiempo completo

    Overview: TFS HealthScience is excited to be expanding our **SRS **team and we are looking for an experienced, highly motivated regional **Clinical Research Associate (CRA)** who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of professionals led by an industry expert. We are a...

  • Senior Clinical Research Associate

    hace 3 días

    Barcelona, España TFS HealthScience A tiempo completo

    Overview: SENIOR CLINICAL RESEARCH ASSOCIATE BARCELONA - SINGLE SPONSOR - ONCO-HEMATOLOGY 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...

  • Clinical Research Associate

    hace 2 días

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    Overview:CLINICAL RESEARCH ASSOCIATE CATALUÑA - SINGLE SPONSORTFS 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...

  • Study Start Up Associate II

    hace 1 semana

    Barcelona, España ICON Clinical Research A tiempo completo

    Study Start Up Associate II At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Senior Clinical Research Associate

    hace 2 días

    Barcelona, Barcelona, España Jr Spain A tiempo completo

    col-wideJob Description:Labcorp Drug Development is currently recruiting for a Senior CRA in Barcelona to work on therapeutic areas Oncology:This particular role is a client dedicated one where you will work exclusively on one sponsor's trials and SOPs; a client that values their staff and puts an emphasis on career development:What makes this opportunity...

  • Senior Clinical Research Associate

    hace 2 días

    Barcelona, Barcelona, España Labcorp A tiempo completo

    Labcorp Drug Development is currently recruiting for a Senior CRA in Barcelona to work on therapeutic areas Oncology:This particular role is a client dedicated one where you will work exclusively on one sponsor's trials and SOPs; a client that values their staff and puts an emphasis on career development:What makes this opportunity special?:- You will be...

  • Clinical Research Associate Ii

    hace 2 semanas

    Barcelona, España ICON plc A tiempo completo

    As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical...

  • Clinical Research Associate Ii

    hace 2 días

    Barcelona, Barcelona, España Fortrea - Organic A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Associate

    hace 3 días

    Barcelona, España TFS HealthScience A tiempo completo

    Overview: TFS HealthScience is excited to be expanding our **CDS **team and we are looking for an experienced, highly motivated **CLINICAL RESEARCH ASSOCIATE (CRA)** 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...

  • Senior Clinical Research Associate

    hace 2 días

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    Overview:SENIOR CLINICAL RESEARCH ASSOCIATE BARCELONA - SINGLE SPONSOR - ONCO-HEMATOLOGYTFS 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...

  • Senior Clinical Research Associate

    hace 7 días

    Barcelona, España ClinChoice A tiempo completo

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a **Clinical Research Associate** in our Clinical Operations department in Spain. Our Clinical Research...

  • Clinical Research Associate 2

    hace 2 meses

    Barcelona, España Veranex, Inc. A tiempo completo

    Veranex 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...