Senior Clinical Research Associate

5 meses atrás

Lisboa, Portugal TFS HealthScience Tempo inteiro

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

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

**Together we make a difference.**

TFS HealthScience is looking for a **Senior Clinical Research Associate** **(Senior CRA) - part-time 0.4 FTE**:

- **home based** **in Portugal.**

**Ophthalmology experience is required - ideally in retinal indications such as Diabetic Macular Edema (DME), Age Related Macular Degeneration (AMD), etc.**

**What can we offer you?**

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

**Portugal** benefits include**:

- Private Health Insurance
- Accident Insurance
- Lunch Allowance
- Homebased Allowance for home-based employees
- Car Allowance for certain roles
- Flexible working schedule - which encourages a balanced work and home life

**Responsibilities**:
The **Senior Clinical Research Associate (Senior CRA)** is part of SRS and COP within TFS Develop and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements.

The **Senior CRA** may assist the Project Manager in certain aspects of project activities which may include project tracking, monitoring plans, review of monitoring reports and CRA resources management.

The **Senior CRA** may also conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed; may involve overnight and international travel.
- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
- Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
- Initiates corrective action to resolve issues as directed by supervisor
- Participate in contract handling and negotiation directed by Lead CRA/Project Manager
- Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
- In cooperation with study team, responsible for SMF maintenance

Qualifications:

- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Min 3 years of experience as CRA including relevant on-site monitoring experience
- Ophthalmology experience is required - ideally in retinal indications such as Diabetic Macular Edema (DME), Age Related Macular Degeneration (AMD), etc.
- Risk based / remote monitoring - mandatory
- Gene Therapy - would be advantageous
- Able to work in a fast paced environment with changing priorities
- Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
- Ability to work independently as well as in a team matrix organization
- Excellent English and Portuguese written and verbal communication skills
- Excellent organizational skills
- Ability and willingness to travel up to 60-70%
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _privacy notice_ for further details._
- TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._

  • Senior Clinical Research Associate

    2 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Job Title: Senior Clinical Research AssociateLocation: Lisbon, PortugalAt Thermo Fisher Scientific, we are seeking an experienced Senior Clinical Research Associate to join our Clinical Operations team in Portugal. As a Senior Clinical Research Associate, you will be responsible for monitoring investigator sites with a risk-based monitoring approach,...

  • Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Cti Clinical Trial Services, Inc Tempo inteiro

    Job Summary: We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Cti Clinical Trial Services, Inc. As a Clinical Research Associate, you will play a critical role in analyzing and researching institutions and investigators to develop site, investigator, and patient information for business development...

  • Senior Clinical Research Associate

    3 meses atrás

    Lisboa, Portugal TFS HealthScience Tempo inteiro

    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** **Senior Clinical Research...

  • Senior Clinical Research Associate

    2 semanas atrás

    Lisboa, Lisboa, Portugal Phiture Tempo inteiro

    Job Title: Senior Clinical Research AssociateWe are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team in Portugal. As a key member of our Clinical Operations team, you will be responsible for managing the recruitment of potential investigators, performing CA and EC submissions, and monitoring clinical...

  • Senior Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Iqvia Llc Tempo inteiro

    Senior Clinical Research AssociateIqvia Llc is seeking a Senior Clinical Research Associate to join our team in Portugal. As a sponsor-dedicated CRA, you will enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers.Responsibilities:Perform site selection, initiation,...

  • Senior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Priovanttx Tempo inteiro

    Job Overview: Priovant is committed to developing therapies that address high unmet need in autoimmune disease. As a Senior Clinical Research Associate at Priovant, you will play a critical role in ensuring the success of our clinical trials. This position is ideal for a highly organized and detail-oriented professional with a strong understanding of...

  • Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    About the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with cross-functional teams to ensure the delivery of high-quality results.Key ResponsibilitiesPerform and coordinate all...

  • Clinical Research Associate

    Há 2 dias

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Senior Clinical Research AssociateWe are seeking an experienced Senior Clinical Research Associate to join our team in Portugal. As a key member of our Clinical Operations group, you will play a crucial role in delivering high-quality clinical trials across commercial and government contracts.About the RoleMonitor investigator sites with a risk-based...

  • Senior Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    About the RoleWe are seeking an experienced Clinical Research Associate to join our team in Portugal. As a key member of our Clinical Operations team, you will be responsible for monitoring investigator sites, ensuring data accuracy, and providing trial status tracking and progress update reports to the CTM.Key ResponsibilitiesMonitor investigator sites with...

  • Clinical Research Associate

    Há 4 dias

    Lisboa, Lisboa, Portugal Resourcing Life Science Tempo inteiro

    Our client, a leading Global Clinical Research Organization (CRO), is currently seeking a skilled Clinical Research Associate to support their diverse range of Pharmaceutical and Biotech clients in Portugal.Key Responsibilities:Monitor clinical studies in phases II-IIIEnsure adherence to Good Clinical Practices and investigator integrityIdentify, qualify,...

  • Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Tfs Healthscience Tempo inteiro

    About TFS HealthScienceTFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our Strategic...

  • Senior Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Unlock Your Potential as a Senior Clinical Research AssociateIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We're driven by a passion to push the boundaries of human science and data science to create a healthier world.As a sponsor-dedicated CRA at IQVIA Portugal,...

  • Senior Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    About the RoleWe are seeking an experienced Senior Clinical Research Associate to join our team in Portugal. As a key member of our Clinical Operations team, you will be responsible for monitoring investigator sites, ensuring data accuracy, and providing trial status tracking and progress update reports to the CTM.Key ResponsibilitiesMonitor investigator...

  • Senior Clinical Research Associate

    3 semanas atrás

    Lisboa, Lisboa, Portugal Ppd Latin America Tempo inteiro

    About the Role:As a Clinical Research Associate at Ppd Latin America, you will play a vital role in ensuring the success of clinical trials. Your primary responsibility will be to monitor investigator sites, applying a risk-based monitoring approach to identify any risks or issues. You will ensure data accuracy through source data review, site data...

  • Senior Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiro

    Senior Clinical Research AssociateIQVIA is a leading global contract research organization that drives human health outcomes forward. As a sponsor-dedicated CRA, you will enjoy the stability and resources of a global company while gaining direct experience with one of our customers.Key Responsibilities:Perform site selection, initiation, monitoring, and...

  • Senior Clinical Research Associate

    2 semanas atrás

    Lisboa, Lisboa, Portugal Ppd Latin America Tempo inteiro

    About the RoleAs a Clinical Research Associate, you will be responsible for monitoring investigator sites with a risk-based approach, applying root cause analysis, and ensuring data accuracy through source data review, source document verification, and CRF review. You will assess investigational products through physical inventory and records review,...

  • Clinical Research Associate II

    4 semanas atrás

    Lisboa, Lisboa, Portugal Icon Strategic Solutions Tempo inteiro

    Job Title: Clinical Research Associate IIAt ICON, we are seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for monitoring multiple Phase I, II, III, and IV clinical trial sites, across different therapeutic areas.Key Responsibilities:Monitor multiple...

  • Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Iqvia Tempo inteiro

    Clinical Research AssociateClinical Research Associates play a crucial role in the success of our clinical trials. As a key member of our team, you will be responsible for ensuring the quality and integrity of site practices in accordance with regulatory requirements.Key Responsibilities:Perform site selection, initiation, monitoring, and close-out visits to...

  • Senior Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Unlock Your Potential as a Senior Clinical Research AssociateIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We're dedicated to driving human health outcomes forward.As a sponsor-dedicated CRA at IQVIA Portugal, you'll enjoy the stability and resources of a leading,...

  • Clinical Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    About the RoleAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Research Associate, you'll play a critical role in supporting our global Clinical Operations team in delivering high-quality, cost-efficient clinical studies.Key ResponsibilitiesPerform and coordinate all aspects...