Clinical Research Associate
il y a 2 jours
We have a very exiting role and looking to hire a
(Junior / Medior / Senior ) Clinical Research Associate
Purpose of the role
Main responsibilities
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased.
- Subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Supports and/or leads audit/inspection activities as needed.
Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
**Profile**:
B.A./B.S. with strong emphasis in science and/or biology.
At least 1 year of direct site management (monitoring) experience in a bio/pharma/CRO.
Fluent in local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Proven Skills in Site Management including independent management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgment.
Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.
Experience with conducting site motivational visit designed to boost site enrollment.
Capable of managing complex issues, works in a solution-oriented manner.
Performs root cause analysis and implements preventative and corrective action.
Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
**Behavioral Competency Expectations**:
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
Able to work highly independently across multiple protocols, sites and therapy areas.
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
Works with high quality and compliance mind-set.
Positive mindset, growth mindset, capable of working independently and being self-driven.
Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more th
-
Clinical Research Associate
il y a 6 jours
Brussels, Belgique Premier Research Temps pleinThe 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 Research Associate
il y a 6 jours
Brussels, Belgique Meet Recruitment Temps pleinCompetitive - Brussels, Belgium - Permanent **Clinical Research Associate - Belgium - Small-Niche CRO - Fast Progression to CTM!** This established organisation is a Small-Niche CRO that has been around for over 22 years. They interact with the clinical and innovation community in order to access breakthrough science and the best sites, talent, and...
-
Clinical Research Associate
Il y a 6 mois
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 trials to ensure that it is conducted, recorded and reported in accordance with the protocol, the principles of Good Clinical Practice (GCP) and...
-
Clinical Research Associate
Il y a 6 mois
Brussels, Belgique Pauwels Consulting Temps pleinIn het kortbrussel / bruxelles bediende, freelancer 40 uur per week - Amandine JansenTalent Acquisition Lead Life Sciences 0032491153475 - **Clinical Research Associate**: - Pharma & Sciences - Clinical Research - Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical...
-
Clinical Research Associate
Il y a 4 mois
Brussels, Belgique BeCRO Temps pleinWe are looking for a motivated person to perform monitoring visits and assist Clinical Project Leaders (CPLs) in clinical operations. The role will require travel mainly in Belgium. As a CRA for Artialis you will be an important member of the clinical team and you will work closely with Clinical Project Leaders and the Data Manager on different clinical...
-
Clinical Research Associate 2
Il y a 6 mois
Brussels, Belgique Veranex, Inc. Temps pleinVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Clinical Research Associate 2
Il y a 7 mois
Brussels, Belgique Veranex, Inc. Temps pleinVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Contract Senior Clinical Research Associate
Il y a 7 mois
Brussels, Belgique Ora Temps plein**POSITION TITLE**: Senior Clinical Research Associate **DEPARTMENT**:Ora Europe **LOCATION**: Remote, Belgium **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug...
-
Clinical Research Associate
Il y a 3 mois
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 Research Associate
Il y a 3 mois
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 7 mois
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...
-
Qbd Clinical
Il y a 6 mois
Brussels, Belgique BeCRO Temps pleinEmployment type: Full time **What do we expect from you as a Clinical Research Associate?**: The Clinical Research Associate is responsible for site management related to clinical trials in different phases and therapeutic areas, ensuring that milestones, timelines and quality of such trials, as outlined by the study protocols, monitoring plans, SOPs, and...
-
Clinical Research Physician
Il y a 7 mois
Brussels, Belgique Lilly Temps pleinAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Clinical Research Physician
Il y a 7 mois
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...
-
Clinical Research Physician
il y a 1 jour
Brussels, Belgique EORTC Temps pleinThe Clinical Research Physician works under the hierarchical supervision of the Head of the Medical Department. Main responsibilities / Major Activities **Strategy**: 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...
-
Senior Clinical Research Associate Contractor
il y a 2 jours
Brussels, Belgique BIORASI LLC Temps plein**We are Growing**! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of. Biorasi is looking for top...
-
Research Associate
il y a 4 jours
Brussels, Belgique Hologic Temps plein**Role: Research Associate I/II** **Business Area: Diagnostics R&D** **Location: On-site** **Liège, Belgium** **Contract type: Full-time permanent** As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day. Diagenode (part of Hologic Inc.) is an international biotech company that...
-
Senior Scientist Clinical Research
il y a 1 jour
Brussels, Belgique MSD Temps pleinDo you have a Master’s or Ph.D. degree in Life Sciences and at least 3 years of experience in monitoring clinical studies and/ or clinical study project management in a pharmaceutical or CRO environment? Are you science driven, autonomous, innovative and team-oriented? Do you want to be part of a team, that pushes the boundaries of global healthcare...
-
Senior Scientist Clinical Research
il y a 1 jour
Brussels, Belgique MSD Temps plein**Job Description**: - Do you have a Master’s or Ph.D. degree in Life Sciences and at least 3 years of experience in monitoring clinical studies and/ or clinical study project management in a pharmaceutical or CRO environment? Are you science driven, autonomous, innovative and team-oriented? Do you want to be part of a team, that pushes the boundaries of...
-
Clinical Research Associate
il y a 6 jours
Brussels, Belgique Pauwels Consulting Temps plein**Job description**: - Responsible for relationship building and management and maintain regular communications with investigator sites - Act as the main point of contact for all site - and study-level questions - Responsible for site and monitoring quality, regulatory and GCP compliance - Conduct and report oversight activities, both remote and onsite...
