20 beste vacatures voor de functie van clinical research in amersfoort, ut (nieuwe medewerkers gezocht)

Senior Clinical Research Associate (Level I)
Thermo Fisher Scientific —Ede
- Fulltime
- Computervaardigheden
- Engels
- Onderzoek
Research Associate, Clinical Compatibility & In-Use
Genmab —Utrecht
- € 38.760 - € 58.140 per jaar
- Online sollicitatie
- Microsoft Excel
- Engels
- Master
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Coloplast —Amersfoort
- € 3.600 - € 4.500 per maand
- Parttime
- CRM-systemen
- Ziekenhuis
- Engels
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ICON Plc —Utrecht
- Fulltime
- Computervaardigheden
- Engels
- Organisatorische vaardigheden
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Community Specialist Zorg-en Revalidatiecentra
Coloplast —Amersfoort
- € 4.500 - € 5.600 per maand
- Online sollicitatie
- Salesforce
- Engels
- Kantoor
12 dagen
PhD Improving Carer Support in Eating Disorders
Universiteit Utrecht —Utrecht Oost
- € 3.059 - € 4.051 per maand
- Fulltime
- Doctor
- Verzorging
- Engels
Snel solliciteren
8 dagen
Postdoc Position in Clinical Immunopeptidomics and Proteomics
Universiteit Utrecht —Utrecht Oost
- € 3.706 - € 5.760 per maand
- E-mail
- Doctor
- Laboratoriumervaring
- Onderzoek
Snel solliciteren
8 dagen
Scientifc Advisor - Specialty
GlaxoSmithKline —Amersfoort
- € 69.525 - € 115.875 per jaar
- Fulltime
- Geneeskunde
- Doctor
- Engels
Clinical Trial Coordinator
Thermo Fisher Scientific —Ede
- Fulltime
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
1 dag
Working Student Project Office (summer period July–October)
Eurofins Netherlands Environment Testing —Amersfoort
- Parttime
- Laboratorium
- Laboratoriumervaring
- Analytisch vermogen
Snel solliciteren
PhD Mental Imagery in Mood Disorders: Cognitive Mechanisms and Implications
Universiteit Utrecht —Utrecht Oost
- € 3.059 - € 4.051 per maand
- Fulltime
- Laboratorium
- Doctor
- Engels
Snel solliciteren
8 dagen
Technical Writer Medical Devices and Combination Products
Kuros Biosciences —Bilthoven
- € 5.100 - € 5.600 per maand
- Fulltime
- Hybride werken
- Doctor
- Engels
- Master
Snel solliciteren
HR Operations Teamlead (fulltime/parttime minimaal 24 uur)
Eurofins Netherlands Environment Testing —Amersfoort
- € 4.000 - € 5.000 per maand
- Parttime
- Laboratorium
- Engels
- Administratieve ervaring
Snel solliciteren
Assistant or Associate Professor in Virology
Universiteit Utrecht —Utrecht Oost
- € 4.925 - € 6.682 per maand
- Fulltime
- Doctor
- Master
- Leidinggevende ervaring
Snel solliciteren
Clinical Trial Associate
ICON Plc —Utrecht
- Fulltime
- Bachelor
7 dagen
Field Application Specialist Genomics (qPCR & Digital PCR)
Bio-Rad Laboratories —Lunteren
- Fulltime
- Microsoft Powerpoint
- Microsoft Excel
- Doctor
Assistant Professor of Clinical Psychology
Universiteit Utrecht —Utrecht Oost
- € 4.925 - € 7.573 per maand
- Fulltime
- Doctor
- Engels
- Master
Snel solliciteren
9 dagen
Associate Product Manager Medical Device
Applied Medical Europe B.V. —Amersfoort
- Fulltime
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Laboranten Organisch & Fysisch
Eurofins Netherlands Environment Testing —Amersfoort
- Dringend op zoek naar kandidaten
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- Reiskostenvergoeding
Snel solliciteren
Laborant
Eurofins Netherlands Environment Testing —Amersfoort
- Avondwerk
- Laboratorium
- Analytisch vermogen
- Communicatieve vaardigheden
- Reiskostenvergoeding
Snel solliciteren

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Senior Clinical Research Associate (Level I)

Thermo Fisher Scientific -
Ede

Nu solliciteren

Vacaturegegevens

Fulltime

Kwalificaties

Computervaardigheden
Engels
Onderzoek
Microsoft Office
Presentatievaardigheden
Bachelor
Computervaardigheden
Medische terminologie
Communicatieve vaardigheden
Tijdmanagement

Volledige vacaturetekst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What You’ll Do:

Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF review as applicable through on-site and remote monitoring activities.Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.

Education and Experience Requirements:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver's license where applicable
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:

Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manages Risk Based Monitoring concepts and processes
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detailand the ability to perceive customers’ underlying issues
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills

Working Conditions and Environment:

Working Conditions and Environment:
Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals.
May also include extended overnight stays.
Exposure to biological fluids with potential exposure to infectious organisms.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.

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clinical research vacatures in amersfoort, ut

Senior Clinical Research Associate (Level I)

Research Associate, Clinical Compatibility & In-Use

Consumer Care Specialist

Clinical Research Associate

Community Specialist Zorg-en Revalidatiecentra

PhD Improving Carer Support in Eating Disorders

Postdoc Position in Clinical Immunopeptidomics and Proteomics

Scientifc Advisor - Specialty

Clinical Trial Coordinator

Working Student Project Office (summer period July–October)

PhD Mental Imagery in Mood Disorders: Cognitive Mechanisms and Implications

Technical Writer Medical Devices and Combination Products

HR Operations Teamlead (fulltime/parttime minimaal 24 uur)

Assistant or Associate Professor in Virology

Clinical Trial Associate

Field Application Specialist Genomics (qPCR & Digital PCR)

Assistant Professor of Clinical Psychology

Associate Product Manager Medical Device

Laboranten Organisch & Fysisch

Laborant

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van clinical research in amersfoort, ut

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