Clinical Research Associate I-FSP

4 weeks ago


Taipei, Taiwan Parexel Full time

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

  • Build relationships with investigators and site staff.

  • Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

    -Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
    -Conduct remote Qualification Visits (QVs).

    • Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.

    • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

    • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

    • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.

    • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

    • Forecast, develop, manage, and revise plans and strategies for:

      -IRB/IEC and MoH / RA submission/approval,
      -Site activation,
      -Patient recruitment & retention.

      • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.

      • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

      • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

      • Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

      • Work in a self-driven capacity, with limited need for oversight.

      • Proactively keep manager informed about work progress and any issues.

        Maintenance (from initiation through close out):

        Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.

        • Build relationships with investigators and site staff.

        • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

        • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

        • Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

        • Address/evaluate/resolve issues pending from the previous visit, if any.

        • Follow-up on and respond to appropriate site related questions.

        • Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

        • Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

        • Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

        • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.

        • Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

        • Conduct remote visits/contacts as requested/needed.

        • Generate visit/contact report.

        • Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

        • Assess & manage test article/study supply including supply, accountability and destruction/return status.

        • Review & follow-up site payment status.

        • Follow-up on CRF data entry, query status, and SAEs.

        • Conduct on-site study-specific training (if applicable).

        • Perform site facilities assessments

        • Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

          Overall Accountabilities from Site Identification to Close out:

          Ensure timely and accurate completion of project goals and update of applicable trial management systems.

          • Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

          • Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.

          • Ensure that assigned sites are audit and inspection ready

          • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

          • Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.

          • Show commitment and perform consistent high quality work.

          • Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.

          • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.

          • Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

          • Provide input and feedback for Performance Development Conversation(s).

          • Proactively keep manager informed about work progress and any issues.

          • Develop expertise to become a subject matter expert.

          • Work in a self-driven capacity, with limited need for oversight.

          • Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

            Skills:

          • Problem solving skills

        • Able to work independently, seeking/taking guidance when necessary.

      • Sound presentation skills.

    • Client focused approach to work.

  • Ability to interact professionally within a client organization with the support of manager or CRAII/III

Flexible attitude with respect to work assignments and new learning.

Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).

Willingness to work in a matrix environment and to value the importance of teamwork.

Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

Sound interpersonal, verbal, and written communication skills.

Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.

Developing ability for effective time management in order to meet study needs, team objectives, and department goals.

Developing ability to work across cultures.

Shows commitment to and performs consistently high quality work.

Ability to successfully work in a (‘virtual’) team environment.

Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

Attention to detail.

Holds a driver’s license where required

Knowledge and Experience:

Previous relevant work experience preferred.


Education:

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

Build relationships with investigators and site staff.

Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
-Conduct remote Qualification Visits (QVs).

Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.

Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.

Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

Forecast, develop, manage, and revise plans and strategies for:

-IRB/IEC and MoH / RA submission/approval,
-Site activation,
-Patient recruitment & retention.

Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.

Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

Work in a self-driven capacity, with limited need for oversight.

Proactively keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.

Build relationships with investigators and site staff.

Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

Address/evaluate/resolve issues pending from the previous visit, if any.

Follow-up on and respond to appropriate site related questions.

Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.

Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

Conduct remote visits/contacts as requested/needed.

Generate visit/contact report.

Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

Assess & manage test article/study supply including supply, accountability and destruction/return status.

Review & follow-up site payment status.

Follow-up on CRF data entry, query status, and SAEs.

Conduct on-site study-specific training (if applicable).

Perform site facilities assessments

Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Overall Accountabilities from Site Identification to Close out:

Ensure timely and accurate completion of project goals and update of applicable trial management systems.

Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.

Ensure that assigned sites are audit and inspection ready

Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.

Show commitment and perform consistent high quality work.

Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.

Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.

Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

Provide input and feedback for Performance Development Conversation(s).

Proactively keep manager informed about work progress and any issues.

Develop expertise to become a subject matter expert.

Work in a self-driven capacity, with limited need for oversight.

Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Skills:

Problem solving skills

Able to work independently, seeking/taking guidance when necessary.

Sound presentation skills.

Client focused approach to work.

Ability to interact professionally within a client organization with the support of manager or CRAII/III

Flexible attitude with respect to work assignments and new learning.

Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).

Willingness to work in a matrix environment and to value the importance of teamwork.

Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

Sound interpersonal, verbal, and written communication skills.

Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.

Developing ability for effective time management in order to meet study needs, team objectives, and department goals.

Developing ability to work across cultures.

Shows commitment to and performs consistently high quality work.

Ability to successfully work in a (‘virtual’) team environment.

Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

Attention to detail.

Holds a driver’s license where required

Knowledge and Experience:

Previous relevant work experience preferred.


Education:

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience



  • Taipei, Taiwan Parexel Full time

    Key Accountabilities:•  Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.•  Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on...


  • Taipei, Taiwan Parexel Full time

    Key Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and...


  • Taipei, Taiwan Parexel Full time

    - Assist in the preparation and organization of clinical trial documentation- Support the maintenance of Trial Master Files (TMFs)- Help with data entry and verification in clinical trial management systems- Attend and contribute to team meetings and training sessions- Support monitoring activities, including remote monitoring tasks- Help prepare reports and...


  • Taipei, Taiwan Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt 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...


  • Taipei, Taiwan Parexel Full time

    Job DescriptionKey Accountabilities:Start-up (from site identification through pre-initiation:Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification...


  • Taipei City, Taiwan MSD Full time

    Job DescriptionTHE OPPORTUNITY1. Permanent opportunity to work with global Pharma2. Exploring for the view of clinical study3. Taiwan , Taipei office basedOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products....


  • Taipei City, Taiwan MSD Full time

    Job DescriptionUnder the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The...

  • Field Service Engineer

    2 months ago


    Taipei City, Taiwan Danaher Full time

    Be part of something altogether life-changing!Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At...


  • Taipei City, Taiwan MSD Full time

    Job DescriptionWe are seeking a highly motivated Regional Trial Initiation, Associate Director to join our team. In this role, you will be responsible for overseeing and executing the review, negotiation, and approval of site budgets and payments on a regional and global scale. You will play a pivotal role in driving process improvement initiatives and...


  • Taipei, Taiwan Danaher Full time

    Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. At first glance, you’ll see we are dedicated to advancing and optimizing the laboratory to move science and health care forward...


  • Taipei, Taiwan State Street Full time

    Who we are looking forFund accountants are primarily responsible for the timely and accurate execution and reporting of net asset valuations (NAVs) for our clients’ accounts (funds).What you will be responsible forAs Fund Accounting & Administration, Associate 2, you will:The fund accountant identifies, analyzes and substantiates impacts to the...


  • Taipei, Taiwan State Street Full time

    Who we are looking forFund accountants are primarily responsible for the timely and accurate execution and reporting of net asset valuations (NAVs) for our clients’ accounts (funds). What you will be responsible forAs Fund Accounting & Administration, Associate 2, you will:The fund accountant identifies, analyzes and substantiates impacts to the...


  • Taipei City, Taiwan Danaher Full time

    Do you want to help advance scientific discovery, improving quality of life around the world? We do, too.Molecular Devices has the opportunity to be the innovation partner that empowers scientists to fast-track research breakthroughs, leading to earlier diagnoses and safer drug treatments. We’re a leading life science solutions provider of...

  • Open Faculty Positions

    4 months ago


    Taipei, Taiwan National Taiwan University (NTU) Full time

    Job SummaryThe Department of Psychology at the College of Science, National Taiwan University is inviting applications for faculty positions at all levels in the following areas: Industrial and organizational psychology Personality/Social psychology Clinical psychology Cognitive/perceptual psychology Developmental psychology (especially with a life-span...

  • Medical Advisor

    4 weeks ago


    Taipei, Taiwan Fyte Full time

    As the Medical Advisor, your primary responsibility is to stay current with medical practices, medications, and trends within the relevant therapeutic area. You will serve as a key liaison between internal teams and external stakeholders, ensuring that the latest medical and scientific insights are incorporated into our strategies. Your role will focus on...

  • Tax Associate

    4 months ago


    Taipei, Taiwan Vialto Full time

    Job Description Company Description Vialto Partners is a market leader in global mobility services. Our purpose is to ‘Connect the world’. We are unique and the only stand-alone global mobility business. This presents a rare opportunity for our clients, stakeholders and colleagues. Our teams help companies streamline and effectively manage their global...


  • Taipei, Taiwan AECOM Full time

    公司簡介Work with Us. Change the World.At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world’s most...


  • Taipei, Taiwan AECOM Full time

    公司簡介Work with Us. Change the World.At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world’s most...

  • Data Scientist, Intern

    4 months ago


    Taipei, Taiwan Philips Part time

    Job TitleData Scientist, InternJob DescriptionJob DescriptionYou are responsible for- Execute comprehensive data analysis and develop predictive models, utilizing advanced statistical and machine learning techniques.- Develop Minimum Viable Product (MVP) applications encompassing the spectrum from model development to model deployment. Engineer scalable,...

  • Marketing Manager

    3 months ago


    Taipei, Taiwan WARNERMEDIA Full time

    Welcome to Warner Bros. Discovery… the stuff dreams are made of.Who We Are… When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of iconic content and beloved brands, are the storytellers...