Clinical Research Associate

2 days ago

kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

  • Bachelor's Degree in scientific discipline or health care preferred.
  • Requires at least 1 year of on-site monitoring experience.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
  • Good therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Written and verbal communication skills including good command of English language.
  • Organizational and problem-solving skills.
  • Effective time and financial management skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Company Overview
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

#J-18808-Ljbffr

  • Clinical Research Associate

    2 days ago

    Kwai Tsing District, Hong Kong SAR China IQVIA Argentina Full time

    Job DescriptionThe Clinical Research Associate will be responsible for monitoring and managing research sites to ensure compliance with study protocols, regulations, and sponsor requirements.Key responsibilities include:Performing site monitoring visits to verify adherence to protocol and regulatory requirements;Working with sites to develop and track...

  • Clinical Research Associate

    2 days ago

    Kwai Tsing District, Hong Kong SAR China IQVIA Argentina Full time

    Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential FunctionsPerform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...

  • Clinical Research Professional

    2 days ago

    kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time

    Job OverviewAt IQVIA, we seek a skilled Clinical Research Associate to ensure that sites are conducting studies and reporting data as required by the study protocol, applicable regulations, and sponsor requirements.This role involves performing site monitoring visits, working with sites to adapt subject recruitment plans, administering protocol training, and...

  • Research Site Manager

    2 days ago

    kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time

    About the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at IQVIA Argentina. In this role, you will be responsible for ensuring the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.You will work closely with sites to monitor their progress,...

  • Clinical Research Associate

    4 weeks ago

    Central And Western District, Hong Kong SAR China ICON Full time

    Clinical Research AssociateWorking Model:Hong Kong Client Office basedAs a Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.What you will be doing:Site MonitoringSite ManagementUltimately responsible for the successful management of investigator sites...

  • Clinical Research Associate

    3 weeks ago

    Central And Western District, Hong Kong SAR China ICON Full time

    Clinical Research AssociateWorking Model:Hong Kong Client Office basedAs a Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Site MonitoringSite ManagementUltimately responsible for the successful management of investigator sites...

  • (Senior) Clinical Research Associate

    4 weeks ago

    Central And Western District, Hong Kong SAR China ICON Full time

    Clinical Research AssociateWorking Model:Hong Kong Client Office basedAs a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.What you will be doing:Site MonitoringSite ManagementUltimately responsible for the successful management of investigator...

  • (Senior) Clinical Research Associate

    3 weeks ago

    Central And Western District, Hong Kong SAR China ICON Full time

    Clinical Research AssociateWorking Model:Hong Kong Client Office basedAs a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Site MonitoringSite ManagementUltimately responsible for the successful management of investigator...

  • Tenure-track clinical professor/clinical associate professor/clinical assistant professor

    4 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Tenure-Track Clinical Professor/Clinical Associate Professor/Clinical Assistant Professor (several posts)Apply now Ref.: 531123 Work type: Full-time Department: Department of Anaesthesiology, School of Clinical Medicine (20100)Categories: Professoriate Staff Applications are invited for appointment as Tenure-Track Clinical Professor/Clinical Associate...

  • Research Study Coordinator

    2 days ago

    Kwai Tsing District, Hong Kong SAR China IQVIA Argentina Full time

    Job SummaryThe Site Management Specialist plays a crucial role in ensuring the smooth conduct of clinical research studies at various sites.Main responsibilities include:Overseeing site initiation and setup processes;Monitoring site performance and identifying areas for improvement;Developing and implementing corrective actions to address any deviations or...

  • Study Quality Assurance Specialist

    1 day ago

    kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time

    Job DescriptionThe Clinical Research Associate will be responsible for ensuring that study sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.This role involves performing site monitoring visits, working with sites to adapt subject recruitment plans,...

  • Clinical Associate Professor of Practice

    4 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Clinical Associate Professor of PracticeApply nowRef.:527347Work type:Full-timeDepartment:Department of Microbiology, School of Clinical Medicine (20700)Categories:Professoriate StaffApplications are invited for appointment asClinical Associate Professor of Practice in theDepartment of Microbiology, School of Clinical Medicine (Ref.: 527347), to commence as...

  • Clinical Associate Professor of Practice

    4 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Clinical Associate Professor of PracticeApply nowRef.:527347Work type:Full-timeDepartment:Department of Microbiology, School of Clinical Medicine (20700)Categories:Professoriate StaffApplications are invited for appointment asClinical Associate Professor of Practice in theDepartment of Microbiology, School of Clinical Medicine (Ref.: 527347), to commence as...

  • Clinical Associate Professor of Practice/ Clinical Assistant Professor of Practice

    4 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Clinical Associate Professor of Practice/ Clinical Assistant Professor of Practice (several posts)The University of Hong KongRef.:530656Work type:Full-timeDepartment:Li Ka Shing Faculty of Medicine (20000)Categories:Professoriate StaffHong KongHKUMed is now seeking exceptional candidates in the following disciplines to join its ranks:Anaesthesiology, Cancer...

  • Clinical Research Manager

    5 days ago

    kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time

    About the RoleThe Site Activation Specialist will execute feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. This includes preparing and managing site documentation, reviewing and negotiating site documents and contracts with sites...

  • Clinical Associate Professor of Practice/ Clinical Assistant Professor of Practice

    4 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Clinical Associate Professor of Practice/ Clinical Assistant Professor of Practice (several posts)The University of Hong KongRef.:530656Work type:Full-timeDepartment:Li Ka Shing Faculty of Medicine (20000)Categories:Professoriate StaffHong KongHKUMed is now seeking exceptional candidates in the following disciplines to join its ranks:Anaesthesiology, Cancer...

  • Regulatory Compliance Officer

    2 days ago

    Kwai Tsing District, Hong Kong SAR China IQVIA Argentina Full time

    Key ResponsibilitiesThe Regulatory Compliance Officer will be responsible for ensuring that all aspects of clinical research studies conducted at our sites comply with applicable laws, regulations, and industry standards.Main duties include:Developing and implementing policies and procedures to ensure regulatory compliance;Conducting audits and assessments...

  • Tenure-track non-clinical assistant professor/associate professor/professor

    4 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Tenure-Track non-Clinical Assistant Professor/Associate Professor/Professor Apply now Ref.: 530601 Work type: Full-time Department: Department of Emergency Medicine, School of Clinical Medicine (22700)Categories: Professoriate Staff Applications are invited for appointment as Tenure-Track Professor/Associate Professor/Assistant Professor jointly held in the...

  • Tenure-track non-clinical assistant professor/associate professor/professor

    3 weeks ago

    Central And Western District, Hong Kong SAR China Hong Kong University Full time

    Tenure-Track non-Clinical Assistant Professor/Associate Professor/Professor Apply now Ref.: 530601 Work type: Full-time Department: Department of Emergency Medicine, School of Clinical Medicine (22700)Categories: Professoriate Staff Applications are invited for appointment as Tenure-Track Professor/Associate Professor/Assistant Professor jointly held in the...

  • Regional Site Liaison

    5 days ago

    kwai tsing district, Hong Kong SAR China IQVIA Argentina Full time

    About the TeamWe are seeking a highly skilled and experienced Site Activation Specialist to join our team at IQVIA Argentina. The ideal candidate will have a strong background in clinical research, excellent communication skills, and the ability to work effectively in a fast-paced environment.ResponsibilitiesPerform site feasibility assessments and identify...