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Clinical research associate • hohenkirchen siegertsbrunn

Zuletzt aktualisiert: vor 12 Tagen
Clinical Research Associates (all levels) - Germany

Clinical Research Associates (all levels) - Germany

Thermo Fisher ScientificMunich, Germany
Vollzeit
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 ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
da Vinci Clinical Sales Associate (gn)

da Vinci Clinical Sales Associate (gn)

Intuitive SurgicalMunich, GERMANY, Germany
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Clinical Research Associate II, Dermatology & Rheumatology, Germany

Clinical Research Associate II, Dermatology & Rheumatology, Germany

InderoMunich, BY, DE
Homeoffice
Unbefristet
Clinical Research Associate II, Dermatology & Rheumatology, Germany.The Clinical Research Associate II (CRA II) will monitor the progress of clinical studies at investigative sites or remotely,...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Research Engineer (m / f / d)

Research Engineer (m / f / d)

MED-EL Medical ElectronicsInnsbruck (Österreich), Germany
Vollzeit
MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousand...Mehr anzeigenZuletzt aktualisiert: vor 22 Tagen
Research Analyst

Research Analyst

ParticulaMunich, Bavaria, Germany
Homeoffice
Quick Apply
Hi, we are Particula, the leading rating and monitoring platform for digital assets! Our mission? To make the market for digital assets more accessible, secure and transparent for institutional inv...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Clinical Research Nurse (m / f / d) Advanced Hemodynamic Management

Clinical Research Nurse (m / f / d) Advanced Hemodynamic Management

PhilipsMunich, Bayern, Germany
Clinical Research Nurse (m / f / d) Advanced Hemodynamic Management.The Clinical Research Associate is responsible for supporting various aspects of clinical research activities, ensuring adherence to ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Research Engineer (m / f / d)

Research Engineer (m / f / d)

MED-ELMünchen, DE
MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousand...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
  • Gesponsert
Professor in » Solid-State Quantum Systems «

Professor in » Solid-State Quantum Systems «

Technische Universität München (TUM)München, Deutschland
In connection with the appointment of a new Director at the Walther-Meißner-Institute (WMI), the Technical University of Munich (TUM) invites applications for the position ofProfessorin » Solid-Sta...Mehr anzeigenZuletzt aktualisiert: vor 17 Tagen
Research Associate (Postdoc) Position (m / f / d) in B Cell Immunology

Research Associate (Postdoc) Position (m / f / d) in B Cell Immunology

Klinikum rechts der IsarMünchen, Bayern, DE
Klinikum rechts der Isar der Technischen Universität München (TUM).Research Associate (Postdoc) Position (m / f / d) in B Cell Immunology. Full- or part-time | temporary (24 month) |.Marc Schmidt-Suppri...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Clinician Services Engagement Associate, Germany (m / f / d)

Clinician Services Engagement Associate, Germany (m / f / d)

WCG ClinicalMunich, Bavaria - Remote
Homeoffice
Clinician Services Engagement Associate works in a pivotal role of managing communication and activities among clinical research sites, and internal stakeholders to prepare for and complete clinica...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
(Senior) Research Manager - Spine & Neurosurgery

(Senior) Research Manager - Spine & Neurosurgery

BrainlabMunich, Bavaria, Germany
Oversee clinical studies, investigations and evaluations, ensuring compliance with EU MDR, FDA and other regulatory requirements. Manage collaborations with CROs and external clinical supp...Mehr anzeigenZuletzt aktualisiert: vor 23 Tagen
  • Gesponsert
Clinical Research Associate - Remote - North / South Germany

Clinical Research Associate - Remote - North / South Germany

PharmiwebMunich, DE
Homeoffice
ICON plc is a world-leading healthcare intelligence and clinical research organization.We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join u...Mehr anzeigenZuletzt aktualisiert: vor 12 Tagen
Senior Clinical Research Associate - Germany - Home based

Senior Clinical Research Associate - Germany - Home based

Worldwide Clinical TrialsMunich, Germany
Requisition Number8065Employment Type : Regular.Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutica...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Director - Patient Safety Physician (gn) : Inflammation

Associate Director - Patient Safety Physician (gn) : Inflammation

ageneo Life Science Experts GmbHMünchen, Bayern, DE
Über uns For a globally leading (bio)pharmaceutical company, we are assigned to recruit an Associate Director Patient Safety Physician (gn) for the therapeutic area Inflammation.Your primary focus ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Research Assistants - Munich

Research Assistants - Munich

Clyde & CoMunich
Job Title Research Assistants - Munich Job Location Munich Job Type Fee earners Country / Territory Germany Region UK & Europe Description. If you're looking for the perfect environment to learn, deve...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Content Creator : Schwerpunkt Research Reports

Content Creator : Schwerpunkt Research Reports

Julian HospMunich, Bavaria, Germany
Homeoffice
Quick Apply
I-UNLIMITED steht für wegweisende Finanzbildung, innovative Ansätze im Bereich nachhaltiger Investmentstrategien sowie Unternehmertum. Zur Verstärkung unseres dynamischen Teams suchen wir einen erfa...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Clinical Trial Manager (PhD)

Associate Clinical Trial Manager (PhD)

MEDPACEMunich, Germany
Medpace is a full-service clinical contract research organization (CRO).We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.Our mi...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Scientific IT-Manager – clinical research (m / w / d)

Scientific IT-Manager – clinical research (m / w / d)

Helmholtz Zentrum MünchenMünchen
Scientific IT-Manager – clinical research (m / w / d).In einer sich schnell verändernden Welt entwickeln wir bahnbrechende Lösungen für eine gesündere Gesellschaft. Unsere Exzellenz liegt in der Forschu...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Clinical Research Associates (all levels) - Germany

Clinical Research Associates (all levels) - Germany

Thermo Fisher ScientificMunich, Germany
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

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 to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our clinical department defines, develops and delivers clinical programmes. Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.

We are currently hiring for experienced CRA's at all levels . We ar open across all locations in Germany. Positions can be fully homebased, fully office based in our Munich or Karlsruhe offices or hybrid. We are open to full-time or 80% FTE. All roles are permanent.

The CRA :

Performs and coordinates all aspects of the clinical monitoring and site management process.

Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation..

Acts as a site processes specialist, ensuring 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.

Ensures audit readiness.

Develops collaborative relationships with investigational sites.

Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

A day in the Life :

Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective / preventive actions to bring the site into compliance and decrease risks.

Ensures data accuracy through SDR, SDV and CRF 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.

Brings up 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 ( 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.

Gives 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 ( 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.

Gives to other project work and initiatives for process improvement, as required.

Education and Experience

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

Full Right to work in Germany

Fluency in English and German language to at least C1 level (note that the interview will be held in German).

Knowledge, Skills, 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 attitude, in-depth investigation for appropriate root cause analysis and decision-making

Ability to handles 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 detail and the ability to perceive customers’ underlying issues

Effective social 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 presentation skills