Clinical Research Associate Contractor

1 semana atrás

Lisboa, Lisboa, Portugal Allucent Tempo inteiro

CATO SMS and Pharm-Olam, LLC have merged to form Allucent

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them.
Allucent is a non-laboratory environment.

We are currently recruiting for a
Portuguese-speaking Clinical Research Associate (CRA) - Contractor to join our team in
Portugal.

The Clinical Research Associate (CRA) - Contractor coordinates and performs site management and monitoring activities within the Site Management department of Allucent's Clinical Trial Operations.

The SCRA monitors site performance and provides mentoring to CRA trainees/CRA I-II study team members. The CRA - Contractor acts as the main line of communication between the participating sites and the Lead CRA/PM.

Location:
Portugal (Portuguese-speaking)

Therapeutic Area:
Oncology, Rare Disease and Pediatric

Availability:
FTE = 0.5

Responsibilities:

Site Management:

  • Prepare/review SIV slides and perform Site Initiation Visits to train and instruct site staff on the study requirements
  • Assist in site activation
  • Perform Monitoring visits to:
- verify that source data and study database are accurate, complete and maintained properly
- verify protocol compliance, including safety reporting and drug handling
- verify all study files are maintained and up to date
- support site staff in preparation for study specific site audits and inspections

  • Perform Closeout visits
  • Perform Prestudy visits, if delegated by SSU
  • Perform centralized and risk based monitoring activities
  • Act as the main line of communication between the study PM/LCRA and the site staff
  • Maintain study related trackers
  • Prepare site visit reports
  • Liaise with site staff to achieve patient recruitment targets
  • Contribute to the development of study specific documents
  • Support the study startup team in preparation of submission packages and collection of site documents, if delegated by SSU
  • Review of site visit reports
  • Assist the study PM/LCRA in coordinating and supporting CRA activities

Management, Learning & Development

  • Actively support site management staff learning & development within the company
  • Perform Co-Monitoring visits
  • Supervise and guide CRA trainees, CRA I and/or CRA II

Quality Management

  • Draft and contribute as Subject Matter Expert (SME) in the field of Site Management activities to the evaluation/improvement of processes and procedures within the Quality Management System

Account Management, Sales & Acquisition

  • Assure good communication and relationships with (future) clients
  • Contribute and take part in client evaluations, visits and bid defenses

Other

  • Contribute to other areas of business as required
  • Contribute to internal and external audits

Requirements:

Qualifications

  • Life science, healthcare, medicine and/or related degree
-
Minimum 3 year of CRA experience:

  • Minimum 3 years of experience in drug development and/or clinical research
  • Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
  • Good understanding of site management and monitoring
  • The ability to perform site visits in an effective way and having performed all different types of site visits (Initiation visit, Monitoring visit and Closeout visits)

Skills:

  • Strong written and verbal communication skills including good command of
    Portuguese and English language
  • Representative, outgoing and client focused
  • Ability to work in a fastpaced challenging environment of a growing company
  • Administrative excellence with attention to detail and accuracy
  • Strong organizational skills
LI_BL1

  • Senior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Senior Clinical Research Associate Sponsor Dedicated based in Portugal Lisboa Senior Clinical Research AssociateSponsor Dedicated based in PortugalLisboa Lisbon, Lisbon, Portugal Senior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Portugal as a- dedicated CRA,...

  • Senior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Senior Clinical Research Associate - Sponsor Dedicated- Based In Portugal Lisboa Senior Clinical Research Associate - Sponsor Dedicated- Based In PortugalLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Senior Clinical Research AssociateIQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you joinIQVIA...

  • Senior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Senior Clinical Research Associate - Sponsor Dedicated- Based In Portugal Lisboa Senior Clinical Research Associate - Sponsor Dedicated- Based In Portugal Lisboa Lisboa, Lisboa, Portugal col-wideJob Description:Senior Clinical Research AssociateIQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you joinIQVIA...

  • Clinical Research Associate

    Há 1 mês

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Job DescriptionAt 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 career goals while taking science a step...

  • Clinical Research Associate

    3 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Job DescriptionAt 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 career goals while taking science a step...

  • Clinical Research Associate

    3 semanas atrás

    Lisboa, Lisboa, Portugal ThermoFisher Scientific Tempo inteiro

    Job DescriptionAt 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 career goals while taking science a step...

  • Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Inc. Tempo inteiro

    Job Description 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 career goals while taking science a step...

  • Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Novo Nordisk Tempo inteiro

    Are you an experienced Clinical Research Associate (CRA) looking for a new opportunity? Are you looking to advance your career in a dynamic and supportive environment? We have an exciting opportunity for you to join our team, based in either Lisbon or Porto Join our team as a Clinical Research Associate and contribute to the development of life-changing...

  • Junior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Novo Nordisk AS Tempo inteiro

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Select how often (in days) to receive an alert: Are you passionate about clinical research? Do you already have some experience as a Clinical Research Associate, Study Coordinator or Clinical Trial Associate? Do you want to build your career in one of...

  • Intern Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal MSD Tempo inteiro

    Job Description:Transmission of practical skills and knowledge through on-the-job training in Clinical Trial Operations, such as:Supporting Senior clinical research associate on clinical trial site management and onsite monitoring activities, in compliance with our company procedures, local laws and regulations, protocol, monitoring plan and associated...

  • Senior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Senior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Portugal as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to...

  • Junior Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Novo Nordisk Tempo inteiro

    The PositionAs a Junior Clinical Research Associate (CRA), you'll be a crucial member in managing and overseeing clinical trials in alignment with established protocols, regulatory guidelines, and company standards. You'll have a significant role in advancing our mission to introduce groundbreaking treatments to patients.Key Responsibilities:Conduct site...

  • Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Novo Nordisk Tempo inteiro

    Clinical Research Associate (CRA) Trainee - LisbonCategory:EducationLocation:Lisbon, Lisbon, PT- Do you have education background in Life Science? And are you looking for an internship where you can explore how to use your theoretical knowledge to make a difference in the life of millions of patients?- If you answer YES to all questions, we may have just the...

  • Clinical Research Associate Ii

    1 semana atrás

    Lisboa, Lisboa, Portugal Labcorp Tempo inteiro

    Labcorp Drug DevelopmentAs a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...

  • Experienced Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiro

    IQVIA is the Human Data Science Company oriented to drive human health outcomes forward.When you join IQVIA Portugal as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring, you'll have...

  • Lead Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal Novo Nordisk Tempo inteiro

    Are you passionate about healthcare innovation and clinical research? Do you care about making a meaningful contribution towards delivering better care for patients with chronic diseases? Do you want to become part of the 3rd largest Global pharmaceutical company by market cap? Then, this is your moment. Apply now and join Novo Nordisk Portugal. Together we...

  • Intern Clinical Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal MSD Tempo inteiro

    Duration: 12 months Are you looking for an internship to learn and develop, take a peek into the professional world while bringing in your individual contribution? Would you like to experience working in one of the biggest multinationals in the pharmaceutical industry? We are looking for a graduating student or Master student; you must be searching for a...

  • Clinial Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal ThermoFisher Scientific Tempo inteiro

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt 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...

  • Clinial Research Associate

    4 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt 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...

  • Clinial Research Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal ThermoFisher Scientific Tempo inteiro

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt 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...