Contract Senior Clinical Research Associate
Il y a 7 mois
**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 and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.** **Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
**The Role**:
Ora's Senior Clinical Research Associate (Sr. CRA) develop strong clinical site relationships and are accountable for performance and compliance for assigned protocols at our sites. Our Sr. CRA's will work with the oversight of the Lead CRA and Line Manager. As a Sr. CRA, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross functionally with Ora's Quality Assurance and Regulatory teams, (any other internal groups they partner with?) and developing relationships with sponsors and sites through all phases of the trial. To be successful, you will need to obtain a deep understanding of various study protocols and be prepared to provide input on site selection and validation activities. After completing all required training, Ora Sr. CRA's will support the site contact and site managers, act as the primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
**What You'll Do**:
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain in-depth understanding of the study protocol and related procedures.
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
- Participate & provide input on site selection and validation activities.
- Perform 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 evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Travel Requirements up to 75%.
- Adhere to all aspects of Ora's quality system.
- Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values
- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
- Responsibilities may differ from the above based on the specific needs of the business.
**What We Look For**:
- _Experience needed for the Role: _
- Bachelor's degree with 3 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education.
- _Additional Skills & Attributes:_
- Ophthalmic experience strongly preferred.
- Capacity to routinely assess protocol and GCP compliance.
- Ability to understand how to properly assess an investigative sites' capabilities to conducting clinical research.
- Demonstrated ability to verify source data to reported data.
- Ability to monitor and report on the progress of the trial from start-up to completion.
- Knowledge of how to select and qualify an investigative site
-
-
Clinical Research Associate
il y a 7 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 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 7 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 7 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 1 jour
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 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
il y a 3 jours
Brussels, Belgique MSD Temps pleinWe 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,...
-
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...
-
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...
-
Qbd Clinical
Il y a 7 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 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 4 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...
-
Senior Scientist Clinical Research
il y a 3 jours
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 3 jours
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...
-
Senior Clinical Research Associate Contractor
il y a 3 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...
-
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...
-
Senior Clinical Project Manager
Il y a 7 mois
City of Brussels, Belgique ClinChoice Inc. Temps pleinClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Senior Clinical Project Manager to join their internal team in Belgium. You will work on projects from our...
-
Icon - Cra Be - Berlin
Il y a 7 mois
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 7 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...
