Cra (Level Ii)

7 mesi fa

Bologna, Italia Thermo Fisher Scientific A tempo pieno

**Essential Functions**:

- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters according to timelines using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.

**Education and Experience**:

- University degree in a science related field
- CRA Qualified as per the Ministerial Decree dated 15/11/2011 and at least 1 year of monitoring experience in clinical development phases II-IV
- Understanding of ICH-GCP, EU and FDA requirements
- Fluency in English and in Italian
- Valid Driver's License

**Knowledge, Skills and Abilities**:

- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as require
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement

  • Cra (Level Ii)

    2 settimane fa

    BOLOGNA, Italia Thermo Fisher Scientific A tempo pieno

    **Essential Functions**:- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.- Ensures data accuracy through SDR, SDV and CRF review as...

  • Cra Bologna

    2 giorni fa

    Bologna, Italia Resourcing Life Science A tempo pieno

    Company Description Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Research Associate home based in Bologna. Job Overview - Monitoring clinical...

  • Cra Bologna

    6 ore fa

    BOLOGNA, Italia Resourcing Life Science A tempo pieno

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally.They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access.They are currently seeking a Clinical Research Associate home based in Bologna.Job Overview- Monitoring clinical studies in...

  • Clinical Research Associate Ii Bologna

    2 giorni fa

    Bologna, Italia Resourcing Life Science A tempo pieno

    **Company Description** Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA home based in Bologna. **Job Overview** - Monitoring clinical studies in phases...

  • Clinical Research Associate Ii Bologna

    6 ore fa

    BOLOGNA, Italia Resourcing Life Science A tempo pieno

    **Company Description**Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally.They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access.They are currently seeking a CRA home based in Bologna.**Job Overview**- Monitoring clinical studies in phases II-III-...

  • Senior Cra

    1 mese fa

    BOLOGNA, Italia Mygwork A tempo pieno

    This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Other Environmental Conditions Office Job Description At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a...

  • Senior Cra

    1 mese fa

    BOLOGNA, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Other Environmental Conditions Office Job Description At PPD, part of 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...

  • Senior CRA

    3 mesi fa

    Bologna, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Other Environmental Conditions Office Job DescriptionAt PPD, part of 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...

  • Senior Cra

    3 settimane fa

    BOLOGNA, Italia Buscojobs A tempo pieno

    At PPD, part of 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...

  • Regulatory Affairs Professional

    3 settimane fa

    Bologna, Emilia-Romagna, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific is seeking an experienced Senior CRA to join our team. As a Senior CRA, you will be responsible for ensuring the quality and integrity of clinical trials by monitoring investigator sites and implementing risk-based monitoring approaches.We are looking for professionals with a strong background in science and a proven track record of...

  • Solar Business Development

    7 mesi fa

    Bologna, Italia Progeco NeXT A tempo pieno

    Progeco NeXT offers high added value services in the following areas: - Multidisciplinary engineering - Project management and field assistance - Inspection and shipping - Training and Progeco NeXT Academy - Technical recruitment - Operation and maintenance - Wind energy Our main goal is to better support our customers, becoming together with their...

  • Solar Business Development

    2 settimane fa

    BOLOGNA, Italia Progeco Next A tempo pieno

    Progeco NeXT offers high added value services in the following areas:- Multidisciplinary engineering- Project management and field assistance- Inspection and shipping- Training and Progeco NeXT Academy- Technical recruitment- Operation and maintenance- Wind energyOur main goal is to better support our customers, becoming together with their protagonists in...

  • 1 Fully-Funded Phd Position, Computational Linguistics, Undeciphered Scripts From The Aegean In[]

    1 settimana fa

    BOLOGNA, Italia Nlp People A tempo pieno

    The Department of Classical Philology and Italian Studies, Alma Mater Studiorum, University of Bologna, in conjunction with the ERC Consolidator project INSCRIBE (Invention of Scripts and their Beginnings), seeks applications for one doctoral scholarship, fully funded for three years, starting on the 1st November 2019. Applications will be considered for...

  • 1 fully-funded PhD Position, Computational Linguistics, Undeciphered Scripts from the Aegean in[...]

    4 giorni fa

    Bologna, Italia NLP PEOPLE A tempo pieno

    The Department of Classical Philology and Italian Studies, Alma Mater Studiorum, University of Bologna, in conjunction with the ERC Consolidator project INSCRIBE (Invention of Scripts and their Beginnings), seeks applications for one doctoral scholarship, fully funded for three years, starting on the 1st November 2019. Applications will be considered...

  • 1 Fully-Funded Phd Position, Computational Linguistics, Undeciphered Scripts From The Aegean In[...]

    1 settimana fa

    BOLOGNA, Italia Nlp People A tempo pieno

    The Department of Classical Philology and Italian Studies, AlmaMater Studiorum, University of Bologna, in conjunction with the ERCConsolidator project INSCRIBE (Invention of Scripts and theirBeginnings), seeks applications for one doctoral scholarship, fullyfunded for three years, starting on the 1st November 2019.Applications will be considered for research...

  • Account Executive, Ii, Msp

    5 giorni fa

    BOLOGNA, Italia Buscojobs A tempo pieno

    Role: Account Executive – IT (MSP) European Territory Assigned Account Executive – for managed IT service provider seeking an experienced Account Executive with a hunter mentality to help drive the growth and development of the clientele base.Work alongside the VP of Sales providing best in class IT solutions and take control of your earning...

  • Istruttore e Personal Trainer

    7 mesi fa

    Bologna, Italia CrossFit 40133 A tempo pieno

    Ricerchiamo un coach non necessariamente con molta esperienza, da poter inserire nel nostro staff con formazione interna sul campo, la figura deve dimostrare attitudine nei rapporti interpersonali e voglia di crescere a livello formativo. Il ruolo da ricoprire sarà coach junior/personal trainer con possibilità di crescita in base agli obiettivi...

  • 1 fully-funded PhD Position, Computational Linguistics, Undeciphered Scripts from the Aegean in[...]

    2 settimane fa

    Bologna, Italia NLP PEOPLE A tempo pieno

    The Department of Classical Philology and Italian Studies, AlmaMater Studiorum, University of Bologna, in conjunction with the ERCConsolidator project INSCRIBE (Invention of Scripts and theirBeginnings), seeks applications for one doctoral scholarship, fullyfunded for three years, starting on the 1st November 2019.Applications will be considered for research...

  • Istruttore E Personal Trainer

    2 settimane fa

    BOLOGNA, Italia Crossfit 40133 A tempo pieno

    Ricerchiamo un coach non necessariamente con molta esperienza, da poter inserire nel nostro staff con formazione interna sul campo, la figura deve dimostrare attitudine nei rapporti interpersonali e voglia di crescere a livello formativo.Il ruolo da ricoprire sarà coach junior/personal trainer con possibilità di crescita in base agli obiettivi...

  • Project Director

    2 mesi fa

    BOLOGNA, Italia Havas Group A tempo pieno

    PROJECT DIRECTOR - (EPC solar)Are you a proven Projects Director seeking a new role?A rare opportunity to join a global leader in the renewable energy sector has become available in my client's construction management team in Italy.The role, a permanent / staff hybrid working position, requires experience in the EPC of utility scale solar PV projects.The...