Assistant Clinical Research Associate

3 settimane fa

Milano, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

The Assistant CRA performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logístical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.

**Essential Functions**:

- Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
- Completes and documents study-specific training.
- Orients and trains on any CRG/study-specific systems.
- Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project.
- Supports to customize Site ICF with site contact details, as needed.Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
- Verifies document collection and RCR submission status; updates site EDL and verifies site information.
- Reviews patient facing materials and review translations, as directed.Supports site staff with the vendor related qualification process, where applicable.
- Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
- Provides support to follow-up on site staff training, as appplicable.
- Coordinates and supports logistics for IM attendance, as directed.
- Supports maintenance of vendor trackers, as directed.
- Coordinates study/site supply management during pre-activation and subsequent course of the study.
- May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
- May perform a specific role profile for FSP opportunities according to Client requests.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Supports Essential Document collection, review and updating in systems, as applicable.
- Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
- Supports ongoing remote review of centralized monitoring tools, as directed.
- Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
- Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
- Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.

**Education and Experience**:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

**_ In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._**

**Knowledge, Skills and Abilities**:

- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents
- Effective oral and written communication skills
- Excellent interpersonal and customer service skills
- Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven flexibility and adaptability
- Ability to work in a team or independently, as required
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboardsExcellent English language and grammar skills

  • Clinical Research Associate Ii

    4 settimane fa

    Milano, Italia Psi Cro Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate Full-time PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. As a...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Psi Cro Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate Full-time PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.As a...

  • Clinical Research Associate II

    3 settimane fa

    Milano, Italia Psi CRO Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate Full-time PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. As...

  • Clinical Research Associate Certificati e Junior

    3 settimane fa

    Milano, Italia AltaBrianza Srl A tempo pieno

    Clinical Research Associate certificati (CRA I, CRA II, Senior CRA I) o prossimi alla certificazione - Milano Per la sede italiana (provincia di Milano) di un’importante CRO, ricerchiamo le seguenti figure professionali: Junior CRA; - Clinical Research Associate I (CRA I); - Clinical Research Associate II (CRA II); - Senior Clinical Research Associate I...

  • Clinical Research Associate Ii

    4 settimane fa

    Milano, Italia Psi Cro Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateFull-timePSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.As a...

  • Clinical Research Associate Ii

    4 settimane fa

    Milano, Italia Psi Cro Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateFull-timePSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.As a...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Psi Cro Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateFull-time PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.As a...

  • Clinical Research Associate

    4 settimane fa

    Milano, Italia CROMSOURCE A tempo pieno

    **Location**: Italy - home based **Schedule**: Full-Time, Permanent CROMSOURCE is currently recruiting for a **Clinical Research Associate** for an internal position, located in Italy. **Position Duties & Responsibilities**: - Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study...

  • Clinical Research Associate

    1 settimana fa

    Milano, Italia Boston Scientific Corporation A tempo pieno

    **Clinical Research Associate**: - Remote Eligible: Remote in Country- Onsite Location(s): Milan, MI, IT**Additional Locations**: Italy-Milan; Italy-Rome **About The Role**: The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world...

  • In House Clinical Research Associate

    1 settimana fa

    Milano, Italia Fortrea A tempo pieno

    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

    3 settimane fa

    Milano, Italia Cromsource A tempo pieno

    **Location**: Italy - home based**Schedule**: Full-Time, PermanentCROMSOURCE is currently recruiting for a **Clinical Research Associate** for an internal position, located in Italy.**Position Duties & Responsibilities**:- Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Tn Italy A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate, Milan Client: PSI Location: Milan Job Category: Other EU work permit required: Yes Job Reference: 84fb1874b3c0 Job Views: 3 Posted: 22.01.2025 Expiry Date: 08.03.2025 Job Description: Job Description As a Clinical Research Associate at PSI Italy, you will enjoy a variety of monitoring tasks...

  • In House Clinical Research Associate

    4 settimane fa

    Milano, Italia Fortrea A tempo pieno

    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 Ii

    3 settimane fa

    Milano, Italia Tn Italy A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate, MilanClient:PSILocation:MilanJob Category:OtherEU work permit required:YesJob Reference:84fb1874b3c0Job Views:3Posted:22.01.2025Expiry Date:08.03.2025Job Description:Job DescriptionAs a Clinical Research Associate at PSI Italy, you will enjoy a variety of monitoring tasks and work on...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Tn Italy A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate, MilanClient:PSILocation:MilanJob Category:OtherEU work permit required:YesJob Reference:84fb1874b3c0Job Views:3Posted:22.01.2025Expiry Date:08.03.2025Job Description:Job Description As a Clinical Research Associate at PSI Italy, you will enjoy a variety of monitoring tasks and work on...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Tn Italy A tempo pieno

    Clinical Research Associate II / Senior Clinical Research Associate, Milan Client: PSI Location: Milan Job Category: Other EU work permit required: Yes Job Reference: 84fb1874b3c0 Job Views: 3 Posted: 22.01.2025 Expiry Date: 08.03.2025 Job Description: Job Description As a Clinical Research Associate at PSI Italy, you will enjoy a variety of monitoring tasks...

  • Clinical Research Associate Specialist

    2 giorni fa

    Milano, Lombardia, Italia IQVIA LLC A tempo pieno

    Clinical Research Associate 2 at IQVIA LLCJob OverviewWe are seeking a skilled Clinical Research Associate 2 to join our team. The ideal candidate will possess strong monitoring and site management skills, ensuring sites conduct studies in compliance with protocols, regulations, and sponsor requirements.Key ResponsibilitiesPerform site monitoring visits,...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia Medpace, Inc. A tempo pieno

    Job Summary: The Clinical Research Associate position at Medpace offers the unique opportunity to have an **exciting career** in the research of drug and medical device development while **making a difference** in the lives of those around them. For those with a **medical and/or health/life science background** who want to explore the research field and...

  • Clinical Research Associate

    2 settimane fa

    Milano, Italia Medpace, Inc. A tempo pieno

    Job Summary: The Clinical Research Associate position at Medpace offers the unique opportunity to have an **exciting career** in the research of drug and medical device development while **making a difference** in the lives of those around them. For those with a **medical and/or health/life science background** who want to explore the research field and be...

  • Clinical Research Associate Role

    7 giorni fa

    Milano, Lombardia, Italia Medpace, Inc. A tempo pieno

    About the Clinical Research Associate RoleMEDPACE offers an exciting opportunity to pursue a Clinical Research Associate career in drug and medical device development. This role enables you to make a difference in people's lives by contributing to the research process.The ideal candidate will have a background in medical or health/life sciences and be eager...