Zobacz więcej Upadek

CRA II and Senior CRA

1 miesiąc temu

Katowice, Polska Pharmiweb Pełny etat
Description

Senior Clinical Research Associate I

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities
  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
    • Assesses site processes
    • Conducts Source Document Review of appropriate site source documents and medical records
    • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
    • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
    • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
    • Verifies site compliance with electronic data capture requirements
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
  • 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.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
  • May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
  • For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I.

    Additional responsibilities include:
    • Site support throughout the study lifecycle from site identification through close out
    • Knowledge of local requirements for real world late phase study designs
    • Chart abstraction activities and data collection
    • As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
    • Identify and communicate out of scope activities to Lead CRA/Project Manager
    • Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
    • Identify operational efficiencies and process improvements
    • Develop country level informed consent forms
    • Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
    • Participate in bid defense meetings

Qualifications

What we’re looking for
  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
  • Ability to manage required travel of up to 75% on a regular basis

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Mamy inne aktualne oferty pracy związane z tym obszarem, które można znaleźć poniżej

  • ihcra

    3 tygodni temu

    Katowice, Silesia, Polska Pharmiweb Pełny etat

    Position is based in Warsaw. PolandAt 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 Nodejs Developer

    3 tygodni temu

    Katowice, Silesia, Polska Code and Pepper Pełny etat

    Senior Nodejs Developer Katowice, śląskie Senior Nodejs Developer Katowice Katowice, Silesian Voivodeship, Polska W Code & Pepper nie będziesz tylko klepać kodu. Zaproponujesz rozwiązania korzystne dla projektu. Staniesz się częścią zespołu, który tworzy produkty mające realny wpływ na życie użytkownikówRozwijaj z nami narzędzie Sohar Health...

  • Senior Developer

    3 tygodni temu

    Katowice, Silesia, Polska Code and Pepper Pełny etat

    Senior Developer Katowice Katowice, Silesian Voivodeship, Polska W Code & Pepper nie będziesz tylko klepać kodu. Zaproponujesz rozwiązania korzystne dla projektu. Staniesz się częścią zespołu, który tworzy produkty mające realny wpływ na życie użytkownikówRozwijaj z nami narzędzie Sohar Health — rozwiązanie, które usprawnia dostęp do...

  • Senior Technical and Reporting Analyst

    3 tygodni temu

    Katowice, Silesia, Polska Eurofins GSC Poland Sp. z o. o. Pełny etat

    Senior Technical and Reporting Analyst Katowice, Silesian Voivodeship Senior Technical and Reporting Analyst Katowice Katowice, Silesian Voivodeship, Polska technologies-expected :SQLPythonSharePointresponsibilities :Be part of digital transformation of ESG and Operations KPI Reporting. Design, build and configure workflows and solutions within the Microsoft...

  • Senior Finance and Accounting Spec. with French @

    3 tygodni temu

    Katowice, Silesia, Polska Capgemini Polska Sp. z o.o. Pełny etat

    Senior Finance and Accounting Spec. with French @ Capgemini Polska Sp. z o.o. Katowice Katowice, Silesian Voivodeship, Polska We work in a hybrid model Recruitment process for this position and onboarding trainings are conducted online. At Capgemini, we're proud to be a global leader in working with companies to transform and manage their business by...

  • Senior Technical and Reporting Analyst

    3 tygodni temu

    Katowice, Silesia, Polska Eurofins GSC Poland Pełny etat

    Senior Technical and Reporting Analyst Katowice Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines...

  • Senior Project Manager

    1 miesiąc temu

    Katowice, Polska Arcadis Pełny etat

    As an Arcadian, you already help us deliver world leading sustainable design, engineering, and consultancy solutions for natural and built assets. You are part of our global business comprising 36, people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we...

  • Senior Powerpages And Web Apps Developer

    3 tygodni temu

    Katowice, Silesia, Polska Scalo Sp. Z O.o. Pełny etat

    Senior Power Pages and Web Apps Developer Miejsce pracy: Katowice Technologie, których używamy Wymagane Power Pages Azure Web Apps Services Angular Power BI SQL O projekcie Uczestnictwo w projekcie dot.rozwiązań do analizy danych z obszaru biotechnologii.Wykorzystywany stos technologiczny: Power Pages, Azure Web Apps Services, Angular, Power BI,...

  • Senior PowerPages and Web Apps Developer

    1 miesiąc temu

    Katowice, Polska Scalo Sp. z o.o. Pełny etat

    Senior PowerPages and Web Apps Developer Miejsce pracy: Katowice Technologie, których używamy Wymagane PowerPages Azure Web Apps Services Angular PowerBI SQL O projekcie Uczestnictwo w projekcie dot. rozwiązań do analizy danych z obszaru biotechnologii. Wykorzystywany stos technologiczny: PowerPages, Azure Web Apps Services, Angular, PowerBI,...

  • Senior Backend Data Engineer

    3 tygodni temu

    Katowice, Silesia, Polska Kalepa Pełny etat

    Senior Backend Data Engineer Katowice, Silesian Voivodeship Senior Backend Data Engineer Katowice Katowice, Silesian Voivodeship, Polska Who are we?Kalepa is a fully remote startup dedicated to enhancing underwriting performance and driving profitable premium growth for the commercial insurance industry. Kalepa's AI-powered Copilot software enables...

  • Senior PowerPages and Web Apps Developer

    3 tygodni temu

    Katowice, Silesia, Polska Scalo Sp. z o.o. Pełny etat

    Senior PowerPages and Web Apps Developer Sosnowiec, śląskie Uczestnictwo w projekcie dot. rozwiązań do analizy danych z obszaru biotechnologii.Wykorzystywany stos technologiczny: PowerPages, Azure Web Apps Services, Angular, PowerBI, SQL.współpraca z zespołami wielofunkcyjnymi w celu opracowania i realizacji POC projektu,weryfikacja aplikacji...

  • Senior PowerPages and Web Apps Developer

    3 tygodni temu

    Katowice, Silesia, Polska SCALO Sp. z o.o. Pełny etat

    Jesteśmy firmą technologiczną. Realizujemy projekty. Budujemy zespoły. Zapewniamy specjalistów do projektów. Za pomocą technologii wspieramy wzrost biznesowy naszych Klientów oraz tworzymy przestrzeń do ciągłego rozwoju naszego zespołu. Nasze Center of Excellence skupia najlepszych specjalistów SCALO, zajmujących się różnymi dziedzinami...

  • Senior PowerPages and Web Apps Developer

    3 tygodni temu

    Katowice, Polska Scalo Sp. z o.o. Pełny etat

    Senior PowerPages and Web Apps Developer Miejsce pracy: Katowice Technologie, których używamy Wymagane PowerPagesAzure Web Apps ServicesAngularPowerBISQLO projekcie Uczestnictwo w projekcie dot. rozwiązań do analizy danych z obszaru biotechnologii.Wykorzystywany stos technologiczny: PowerPages, Azure Web Apps Services, Angular, PowerBI, SQL.Twój zakres...

  • Senior Unix Engineer

    3 tygodni temu

    Katowice, Silesia, Polska NTIATIVE sp. z o.o. Pełny etat

    Senior Unix Engineer (Solaris) Katowice, Silesian Voivodeship Senior Unix Engineer (Solaris) Katowice Katowice, Silesian Voivodeship, Polska technologies-expected :AnsiblePuppetRed Hat SatelliteVMWare vSpheretechnologies-optional :AWSCA Spectrumabout-project :For the company we're collaborating with, we are looking for a Senior Unix Engineer with deep...

  • Senior PowerPages and Web Apps Developer

    3 tygodni temu

    Katowice, Silesia, Polska SCALO Sp. z o.o. Pełny etat

    Senior PowerPages and Web Apps Developer (Azure, Angular, SQL) Sosnowiec, śląskie Jesteśmy firmą technologiczną.Realizujemy projekty. Budujemy zespoły. Zapewniamy specjalistów do projektów.Za pomocą technologii wspieramy wzrost biznesowy naszych Klientów oraz tworzymy przestrzeń do ciągłego rozwoju naszego zespołu. Nasze Center of Excellence...

  • Senior Java Developer

    3 tygodni temu

    Katowice, Silesia, Polska Link Group Pełny etat

    Senior Java Developer / Tech Leader @ Link Group Katowice Katowice, Silesian Voivodeship, Polska Bachelor's degree in Computer Science, Engineering, or a related fieldProven experience as a Senior Java Developer or in Java Tech Leader roleStrong understanding of front-end technologies and how they integrate with back-end servicesExperience with Angular (nice...

  • Senior CPQ Administrator

    3 dni temu

    Katowice, Polska Relativity Pełny etat

    We work hybrid: 2 times a week in our Krakow office or 4 times a year for employees from other cities. ð Overview Here at Relativity we prioritize flexibility and work-life harmony. Our Hybrid work environment provides options tailored to your role and location, aiming to enhance engagement, connectivity, and productivity. Join us to experience a...

  • Senior Jira Technical Consultant

    3 tygodni temu

    Katowice, Silesia, Polska Cyclad Sp. z o.o. Pełny etat

    Senior Jira Technical Consultant Pracodawca Dodano PL24/Remote/IC/Senior Jira Technical Consultant In Cyclad we work with top international IT companies in order to boost their potential in delivering outstanding, cutting edge technologies that shape the world of the future. For our customer, leader in consulting, technology services and digital...

  • Senior CPQ Administrator

    1 miesiąc temu

    Katowice, Polska Relativity Pełny etat

    Location: Katowice Department: Information Technology Work Status: Full-time Location Type: Remote Overview Here at Relativity we prioritize flexibility and work-life harmony. Our Hybrid work environment provides options tailored to your role and location, aiming to enhance engagement, connectivity, and productivity.Join us to experience a...

  • Senior AI ML Engineer

    3 tygodni temu

    Katowice, Silesia, Polska Sii Pełny etat

    Senior AI ML Engineer Katowice, Silesian Voivodeship Senior AI ML Engineer Katowice Katowice, Silesian Voivodeship, Polska Join Sii and help develop highly specialized software and IT tools for legal, tax, accounting, trading, and compliance professionals, in conjunction with the world's largest information serviceAs a Senior AI/ML Engineer, you will be part...