Clinical Research Associate Ii
il y a 2 semaines
The Clinical Research Associate II (CRA II) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support. Position is full time or part-time ( 80%) and home-based in the Netherlands or Belgium.
**ROLE RESPONSIBILITIES**:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Maintains submission of expenses according to travel and expense requirements within company guidelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Plans day to day activities for monitoring of a clinical study and sets priorities per site
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
- Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
- Monitors with knowledge of quality/scope/timeline and budget parameters
- Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
- Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member
- Manages query resolution process with sites and Premier Research Data Management
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates
- Assists project team with assessing project feasibility and recruitment, as applicable
Participates in Investigators’ Meeting as designated by the Project Manager
- Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts
- Attends meetings as required
- Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
- Completes timely entry of hours worked and project codes per time entry guidelines
Acquire basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge
Maintains proper, timely communication with study teams and management, as needed
- Completes all required internal training (general and study-specific) on-time
- Identifies confidential information and complies with global and local laws and guidelines
- In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
- In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
- Other activities as designated
- Acts as a resource for other CRAs and shares knowledge base and best practices.
**REQUIREMENTS**:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Previous clinical research experience required, completion of CRA training program
- Read, write and speak fluent English; fluent in host country language (Dutch/French)
- Successful previous experience at Level 1
- At least 2+ years’ experience in clinical trials
- Global experience preferred
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web based communication tools for conferences and any other IT systems require
-
Clinical Trial Associate
il y a 3 semaines
Brussels, Belgique RBW Consulting Temps pleinJob Title: Clinical Trial Associate Location: Hybrid in Brussels Company: Small CRO RBW Consulting is partnered with a small CRO that are looking to hire a Clinical Trial Associate into their growing organization. This company have a highly motivated team, very qualitative conduct, and allow opportunities for personal evolution and to expand their...
-
Ihcra Ii
il y a 4 jours
Brussels, Belgique Fortrea Temps pleinAs 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
il y a 2 semaines
Brussels, Belgique EORTC Temps pleinThe Clinical Research Associate (CRA) works under the hierarchical supervision of the Head of Monitoring. Main responsibilities / Major Activities The CRA is responsible for “on-site” monitoring of clinical trial to ensure that it is conducted, recorded and reported in accordance with the protocol, the principles of Good Clinical Practice (GCP) and the...
-
Icon - Cra Be - Berlin
il y a 3 jours
Brussels, Belgique Meet Recruitment Temps plein55000 EUR - 55000 EUR - Brussels, Belgium - Permanent Clinical Research Associates at a top 10 CRO in Belgium - CRA I - CRA II - SCRA _ 1. Position: Clinical Research Associate I (CRA I) - 53K average salary_ Our client, a leading Clinical Research Organization (CRO) ranked among the top 10 globally, is actively seeking a talented and motivated Clinical...
-
Clinical Research Associate
il y a 6 jours
Brussels, Belgique MSD Temps pleinAs part of a dynamic and passionate team, the Clinical Research Associate is the laboratory's ambassador to the centers, and the defender of the entire product portfolio. He/she plays a key role in all phases of a study, and assumes overall responsibility for the conduct of clinical studies at assigned sites. **Responsibilities include, but are not limited...
-
Clinical Research Associate
il y a 4 semaines
Brussels, Belgique Thermo Fisher Scientific Temps plein**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office 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...
-
Clinical Trial Associate
il y a 2 semaines
Brussels, Belgique Thermo Fisher Scientific Temps pleinOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Clinical Research Associate
il y a 2 semaines
Brussels, Belgique Thermo Fisher Scientific Temps pleinAt 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 beyond through...
-
(Senior) Clinical Research Associate
il y a 1 semaine
Brussels, Belgique Thermo Fisher Scientific Temps pleinPPDis a leading global contract research organization providing comprehensive,integrated drug development, laboratory and lifecycle management services. Ourclients and partners include pharmaceutical, biotechnology, medical device,academic and government organizations. With offices in 48 countries and morethan 21,000 professionals worldwide, PPD applies...
-
Clinical Research Physician
il y a 3 semaines
Brussels, Belgique EORTC - European Organisation for Research and Treatment of Cancer Temps pleinThe Clinical Research Physician works under the hierarchical supervision of the Head of the Medical Department.Main responsibilities / Major ActivitiesStrategy: Clinical Research Physician (CRP) supports the EORTC Research Groups in the elaboration of their scientific strategies to improve standards of care. CRP contributes to build collaboration strong...
-
Clinical Research Administrative Support
il y a 3 jours
Brussels, Belgique Oxford Global Resources Temps plein**Clinical Research Administrative Support**: - Location: Brussels, Belgium - Contact: Aurore Munaut - Job type: Contract - Contact phone: +32 10 68 53 31 - Industry: Life Sciences Do you have a Scientific degree, fluent in English, Dutch and French and willing to step in clinical research ? We may have the perfect position for you; a varied job in one of...
-
Clinical Research Leader
il y a 4 semaines
Brussels, Belgique WhatJobs Temps pleinJob Description - Clinical Research Leader (2506232901W) Clinical Research Leader - 2506232901W Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are...
-
Clinical Research Nurse
il y a 3 semaines
Brussels, Belgique Actalent Temps pleinClinical Research Nurse2 days ago Be among the first 25 applicantsA leading CRO is working very closely with sites across Belgium. They are looking for a Clinical Research Coordinator/Nurse in Brussels, Belgium. The Clinical Research Coordinator/Nurse will have exposure working on clinical trials for their main sponsors.This position will be 0.4 FTE and a...
-
Cra Ii
il y a 4 jours
Brussels, Belgique Precision for Medicine Temps pleinPrecision for Medicine, Oncology and Rare Disease is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two...
-
Clinical Research Physician
il y a 1 semaine
Brussels, Belgique EORTC Temps pleinThe Clinical Research Physician provides medical expertise and support for the development, implementation, conduct and reporting of EORTC clinical trials. He/she also supports the EORTC Research Groups in the elaboration of their scientific strategies to improve standards of care. Main responsibilities / Major Activities Strategy Clinical Research...
-
Clinical Research Physician
il y a 5 jours
Brussels, Belgique EORTC Temps pleinThe Clinical Research Physician provides medical expertise and support for the development, implementation, conduct and reporting of EORTC clinical trials. He/she also supports the EORTC Research Groups in the elaboration and implementation of their scientific strategies to improve standards of care. Main responsibilities / Major Activities Clinical...
-
Monitor (Ich, Gcp)/ Clinical Research Associate
il y a 1 semaine
Brussels, Belgique European Huntington's Disease Network Temps plein**Monitor / Language Area Coordinator** **(part-time: 50-60%)** **What is the European Huntington’s Disease Network (EHDN)?** The EHDN is a non-profit research network committed to advancing research, facilitating the conduct of clinical trials, and improving clinical care in HD. Through the EHDN a platform has been created such that basic scientists,...
-
Clinical Research Manager
il y a 5 jours
Brussels, Belgique MSD Temps pleinWe have an exciting new job opportunity at our location in Brussels and are looking to hire a Clinical Research Manager This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and...
-
Clinical Research Assistant
il y a 4 jours
Brussels, Belgique Express Medical Temps plein**Description**: Vous êtes** infirmier (h/f/x) **? Vous recherchez un n**ouveau défi et portez un intérêt à la recherche clinique** ? **_Nous avons une opportunité pour vous !_** Express Medical recrute actuellement un **Clinical Trial Assistant.** **Votre mission** : vous collaborez avec le Project Manager/Study Coordinator dans la réalisation des...
-
Clinical Trial Coordinator
il y a 1 semaine
Brussels, Belgique Thermo Fisher Scientific Temps pleinOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
