Clinical Research Associate I

hace 4 semanas

Murcia, Murcia, España Pharmiweb A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities
  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
  • Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions.
  • Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
  • Demonstrate diligence in protecting the confidentiality of each subject/patient.
  • Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
  • Conduct Source Document Review of appropriate site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
  • Utilize available hardware and software to support the effective conduct of the clinical project data review and capture.
  • Verify site compliance with electronic data capture requirements.
  • Perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
  • Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
  • Verify issues or risks associated with blinded or randomized information related to IP.
  • Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned.
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
  • Reconcile contents of the ISF with the Trial Master File (TMF).
  • Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
  • Support subject/patient recruitment, retention, and awareness strategies.
  • Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
  • Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
  • Must be able to quickly adapt to changing priorities to achieve goals/targets.
  • May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).
  • Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
  • Participate in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
  • Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
  • For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I.
Qualifications
  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills and be able to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.

  • Clinical Research Associate I

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Clinical Research Associate I Job DescriptionWe are seeking a highly skilled Clinical Research Associate I to join our team at Pharmiweb. As a Clinical Research Associate I, you will be responsible for conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and...

  • Clinical Research Associate II

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job SummaryAs a leading global contract research organization (CRO), Fortrea is seeking a highly skilled Clinical Research Associate II to join our team. With a passion for scientific rigor and decades of clinical development experience, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient...

  • Clinical Research Associate II

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Clinical Research Associate II Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team at Pharmiweb. As a Clinical Research Associate II, you will be responsible for conducting site monitoring responsibilities for clinical trials according to our Standard Operating Procedures (SOPs), ICH guidelines,...

  • Clinical Associate

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    We are seeking a Clinical Associate to support the planning, execution, and monitoring of clinical trials at Pharmiweb. The ideal candidate will have a strong background in life sciences and experience in clinical research or healthcare.Key Responsibilities:Assist in the planning and execution of clinical trials, ensuring adherence to protocol requirements...

  • Clinical Research Associate II

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job SummaryPharmiweb is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for conducting site monitoring responsibilities for clinical trials, ensuring the protection of subjects, and safeguarding data integrity.Key Responsibilities:Conduct site...

  • Clinical Research Manager

    hace 3 días

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Clinical Research ManagerShape the future of clinical developmentAt Pharmiweb, we're proud to foster an inclusive environment driving innovation and excellence. We're currently seeking a Clinical Research Manager to join our diverse and dynamic team in a sponsor dedicated position. As a leader in our research department, you will be responsible for...

  • Clinical Research Manager

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    We are seeking a Clinical Research Manager to oversee the planning, execution, and successful completion of clinical trials. The ideal candidate will ensure adherence to timelines, budgets, and regulatory guidelines.Key responsibilities include:Plan and manage all aspects of clinical trialsCollaborate with cross-functional teams to establish and implement...

  • Clinical Associate

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job Title: Clinical AssociateWe are seeking a highly skilled Clinical Associate to join our team in Barcelona, Spain. As a Clinical Associate, you will play a crucial role in the planning, execution, and monitoring of clinical trials.Key Responsibilities:Assist in the planning and execution of clinical trials, ensuring adherence to protocol requirements,...

  • Clinical Research Associate II

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job SummaryAs a Clinical Research Associate II at Pharmiweb, you will play a critical role in the success of our pharmaceutical trials. We are seeking a highly skilled and experienced professional to join our team as a Site Management Expert.Key ResponsibilitiesConduct site monitoring responsibilities for clinical trials according to our Standard Operating...

  • Principal Biostatistician

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job SummaryAs a Principal Biostatistician at Syneos Health, you will play a key role in leading clinical research projects, collaborating with cross-functional teams, and developing statistical plans to ensure high-quality data analysis.Key ResponsibilitiesLead the development of statistical analysis plans, including the creation of mock-up displays for...

  • Clinical Research Project Manager

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job SummaryICON 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 us on our mission to shape the future of clinical development.About the RoleWe're looking for an experienced Project Manager to join our EU based team....

  • Clinical Trials Manager

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Clinical Trial Manager Job DescriptionClinical Trial Manager - Sponsor Dedicated (global) 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 us on our mission to shape the future of clinical development.We are...

  • Clinical Trial Manager

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    We are seeking a Clinical Trial Manager to oversee the planning, execution, and successful completion of clinical trials at ICON.This critical role involves ensuring adherence to timelines, budgets, and regulatory guidelines.As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide...

  • Clinical Trials Manager

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    We are seeking a Clinical Trial Manager to join our team at ICON in a sponsor dedicated position.This critical role involves overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.As a leader in our research department, you will collaborate with cross-functional...

  • Clinical Trial Manager

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    We are seeking a Clinical Trial Manager to join our team at ICON in a sponsor dedicated position.This critical role involves overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.As a leader in our research department, you will collaborate with cross-functional...

  • Clinical Trial Manager

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    We are seeking a Clinical Trial Manager to oversee the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the...

  • Clinical Trial Manager

    hace 4 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job Summary:Fortrea is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for the execution and oversight of local operational clinical trial activities, ensuring compliance with regulatory and financial requirements.Key Responsibilities:Execution and oversight of local operational clinical...

  • Clinical Financial Analyst

    hace 3 semanas

    Murcia, Murcia, España Pharmiweb A tiempo completo

    Job Overview: As a Clinical Financial Analyst at Pharmiweb, you will be responsible for managing financial reporting for grant payment budgets, including forecasting, reconciliation, and generating reports at the study level. This role requires strong analytical and problem-solving skills, as well as excellent communication and writing skills.Key...

  • Research Scientist

    hace 2 semanas

    Murcia, Murcia, España Universidad Católica San Antonio De Murcia A tiempo completo

    **UCAM-SENS Initiative**The Universidad Católica San Antonio De Murcia is seeking a highly skilled postdoctoral researcher to join our UCAM-SENS initiative, a scientific project focused on the digital transformation of key domains such as Health, Sport, Food, and the Environment.Our MissionOur mission is established on four pillars:RESEARCH: synergy of...

  • Clinical Operations Specialist

    hace 2 días

    Murcia, Murcia, España Pharmiweb A tiempo completo

    About the Role Pharmiweb, a global leader in clinical research, is seeking a skilled Clinical Operations Specialist to join our team. As a Study Delivery Specialist, you will play a vital role in ensuring the success of our clinical trials. Job Summary We are looking for an experienced professional with excellent technical skills to manage study systems,...