Clinical Research Associate Ii
2 settimane fa
For our Commercial offices, based in Rome, we are looking for a Clinical Research Associate II, with following responsibilities:
- Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie
- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
- Minimum of 3 year of clinically-related experience. Experience in on-site monitoring of investigational drug or device trials is required
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.
-
Clinical Research Associate II
1 settimana fa
Roma, Italia Barrington James A tempo pienoClinical Research Associate II - Ophthamology - Italy Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable...
-
Clinical Research Associate, Italy
1 mese fa
Roma, Italia EastHORN Clinical Services A tempo pieno**Job summary**: As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties....
-
Clinical Research Associate Ii
1 mese fa
Roma, Italia ABBVIE A tempo pieno**Key responsibilities**: - Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring...
-
Clinical Research Associate, Site Management
1 settimana fa
Roma, Italia IQVIA LLC A tempo pienoClinical Research Associate, Site Management - Italy page is loaded Clinical Research Associate, Site Management - Italy Apply locations Milan, Italy time type Full time posted on Posted Yesterday job requisition id R1415148 Job Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring...
-
Clinical Research Associate III
1 settimana fa
Roma, Italia Barrington James A tempo pienoClinical Research Associate III - Ophthamology - Italy Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable...
-
Postdoctoral Research Associate
1 settimana fa
Roma, Lazio, Italia University of Liverpool A tempo pienoFollowing a successful grant application to the UK Arts and Humanities Research Council we are seeking to recruit one 60% FTE (i.e. 3 days per week) Postdoctoral Research Associate, for a 9-month fixed period, based in Rome, Italy.The Project entitled The Other Rome: Centring People and Spaces of Maintenance is a collaboration between the Liverpool School of...
-
Clinical Associate Professor
2 settimane fa
Roma, Italia United States Institute for Theatre Technology A tempo pienoClinical Associate Professor (Scenery/Props) Sands College of Performing Arts at Pace University is seeking a full-time Associate Clinical Professor to teach design and stagecraft courses (independently or collaboratively) and maintain a high level of support for the artistic production and academic goals of students and the University, including mentoring...
-
Clinical Research Manager
1 settimana fa
Roma, Italia Fortrea A tempo pienoClinical Research Manager - Home Based Italy 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...
-
Clinical Research Associate
3 settimane fa
Roma, Italia Optimapharm A tempo pienoLocation: home-based Who are we? Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations. With 27 strategically located offices , Optimapharm operates in 40+...
-
Clinical Research Site Monitor
3 settimane fa
Roma, Italia Parexel International A tempo pienoAt Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that...
-
Clinical Specialist
3 settimane fa
Roma, Italia Masimo Corporation A tempo pienoCentral Italy Job Summary: The Clinical Specialist is an entry level role responsible for supporting Masimo Products and maintaining customer relationships with a variety of clinicians and other key stakeholders. Duties & Responsibilities: You will be seen as an expert in pulse oximetry and pulse CO-Oximetry as well as an authority on the clinical impact...
-
Clin Res Assoc Ii
4 settimane fa
Roma, Italia Labcorp A tempo pieno**Clinical Research Associate 2 / CRA 2 - Multi - Sponsor Team**: **Location: Italy**: **A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas - improving...
-
Senior CRA
3 settimane fa
Roma, Italia Barrington James Limited A tempo pienoBarrington James is actively recruiting for a challenging role as a Clinical Research Associate (CRA II). As part of our clients in-house team, you will be responsible for site management, encompassing start-up activities both on-site and remotely across Italy. This role involves working on diverse projects from our client base, which includes small to...
-
Global Clinical Start up Manager Italy
3 settimane fa
Roma, Italia Resourcing Life Science A tempo pienoCompany 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 Start up Manager home based in Italy. Job Overview Leading cross-functional project...
-
Clinical Innovation
2 giorni fa
Roma, Italia Novo Nordisk A tempo pienoClinical Innovation & Implementation Manager **Category**:Clinical Development**Location**:Roma, Lazio, IT- **The Position** - As our Innovation and Implementation Manager, you will be responsible for leading and implementing innovative clinical projects, as well as tracking and analysing clinical activities throughout CDC Italy, with the aim of maximizing...
-
Associate Professor
1 mese fa
Roma, Italia Ningbo University A tempo pienoAll successful applicants can expect: - a one-off funding of 1 million RMB (~140K USD) for full time/ 0.5 million RMB (~70K USD) for part time for individual - weekly salaries starting from 15K RMB ~ 50K RMB (~2.5K to 7K USD) for individual * * Position: Positions are open at five distinct ranks: Postdoctoral Fellow,Assistant Professor, Associate...
-
Roma, Italia Randstad Italia Spa A tempo pienoMansione Hai esperienza in ambito di processi di sintesi organica? Appartieni alle categorie protette secondo articolo 1 della legge 68/99? Randstad Talent Selection Hopportunities è la divisione specializzata nella Ricerca &, Selezione di professionisti qualificati appartenenti alle categorie protette. Ricerchiamo Research Associate per primaria realt...
-
Senior Clinical Trial Manager
7 giorni fa
Roma, Italia ICON A tempo pienoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Associate Start Up Project Manager I
4 settimane fa
Roma, Italia Labcorp A tempo pieno**Associate Start Up Project Manager I, EMEA, Remote** Helping our clients make their clinical trials a success by orchestrating the efforts of top-talented Clinical Research Teams. As Associate Start Up Project Manager I you will primarily oversee and manage the amendment phase of domestic and/or international clinical trials. Responsibilities include...
-
Jr Research Scientist Scientific Departments
4 settimane fa
Roma, Italia IRBM S.p.A. A tempo pienoIRBM is a drug discovery and development company with a track record of success in accelerating and executing the translation of novel discoveries into clinically relevant therapeutic entities, including small molecules, peptides and monoclonal antibodies. IRBM is headquartered in Pomezia (Rome), Italy and provides several integrated pre-clinical laboratory...