Clinical Research Associate I

2 days ago

North Ryde, New South Wales, Australia Isatis Business Solutions Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate I to join our team at Isatis Business Solutions. As a Clinical Research Associate I, you will be responsible for managing clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals and maintaining compliance with ICH-GCP and applicable international and local regulations.

Key Responsibilities
  • Act as the primary point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff to ensure overall integrity of study implementation and adherence to study protocol.
  • Conduct feasibility and/or site pre-qualification and qualification activities, including preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • 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, and 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.
Requirements
  • Previous relevant work experience preferred.
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
  • 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.
  • Holds a driver's license where required.

  • Clinical Research Associate I

    7 days ago

    North Ryde, New South Wales, Australia Parexel Full time

    Job SummaryParexel is seeking a highly skilled Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will be responsible for managing clinical sites, ensuring compliance with regulatory requirements, and providing exceptional customer service to our clients.Key ResponsibilitiesSite Management: Act as Parexel's direct point...

  • Clinical Research Associate I

    7 days ago

    North Ryde, New South Wales, Australia Intelliserve Konsulting Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate I to join our team at Intelliserve Konsulting. As a key member of our site management team, you will be responsible for ensuring the successful execution of clinical trials at assigned sites.Key ResponsibilitiesAct as the primary point of contact for assigned sites, ensuring timely and...

  • Clinical Research Associate I

    7 days ago

    North Ryde, New South Wales, Australia Intelliserve Konsulting Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate I to join our team at Intelliserve Konsulting. As a key member of our site management team, you will be responsible for ensuring the successful execution of clinical trials at assigned sites.Key ResponsibilitiesAct as the primary point of contact for assigned sites, ensuring timely and...

  • Research Associate

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    About the RoleThe Macquarie University Centre for Economic Impacts of Genomic Medicine (GenIMPACT) is seeking a highly skilled Research Assistant in Clinical Genomics to join our dynamic team.Key ResponsibilitiesCoordinate recruitment, consent, and data collection for research grants on the economic and social impact of genetic conditions on...

  • Research Assistant

    6 hours ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    Primary ResponsibilitiesThe Macquarie University Centre for Economic Impacts of Genomic Medicine (GenIMPACT) is seeking a Research Assistant in Clinical Genomics to coordinate recruitment, consent, and data collection for research grants on the economic and social impact of genetic conditions on families. The successful candidate will also assist in...

  • Clinical Research Coordinator

    3 days ago

    North Adelaide, South Australia Vanderbilt University Medical Center Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Vanderbilt University Medical Center. The successful candidate will be responsible for coordinating the approval processes and conduct of research protocols, ensuring the integrity and quality of clinical/translational research.Key...

  • Research Assistant

    6 hours ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    About the RoleWe are seeking a highly skilled and enthusiastic research assistant to support the work of the Centre for Health Systems and Safety Research. The successful applicant will work within the Health Analytics and Patient Safety stream, liaising with academics, research and administrative staff, as well as external stakeholders from the health...

  • Clinical Research Coordinator

    7 days ago

    North Adelaide, South Australia Vanderbilt University Medical Center Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Vanderbilt University Medical Center. The successful candidate will be responsible for coordinating the approval processes and conduct of research protocols, ensuring the integrity and quality of clinical/translational research.Key...

  • Clinical Exercise Specialist

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    Position Overview We are seeking a dedicated Exercise Physiologist to collaborate with research personnel and clinical trial participants in executing clinical research study activities focused on dementia risk mitigation. Key Responsibilities Compensation: Competitive salary ranging from $80,753 to $91,815 (HEW Level 5) plus 17% employer superannuation and...

  • Clinical Services Coordinator

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    PRIMARY DETAIL Exciting opportunity to enhance the operational efficiency of chiropractic clinics at Macquarie University. THE ROLE Salary Package: Pro-rata $74,062 - $79,823 (HEW 4), plus 17% employer's superannuation and annual leave loading Appointment Type: Part Time, 4 days per week, continuing role This position plays a vital role in...

  • Clinical Exercise Specialist

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    Position Overview We are seeking a dedicated Clinical Exercise Specialist to collaborate with research personnel and participants in clinical trials focused on dementia risk mitigation. Key Responsibilities Compensation: Salary range from $80,753 to $91,815 (HEW Level 5) along with 17% employer superannuation and annual leave loading. Employment Type:...

  • Clinical Exercise Specialist

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    Position Overview We are looking for a dedicated Exercise Physiologist to collaborate with research personnel and clinical trial participants in executing clinical research activities focused on dementia risk mitigation. Key Responsibilities Compensation: Salary range from $80,753 - $91,815 (HEW Level 5) plus 17% employer superannuation and annual leave...

  • Healthcare Clinic Operations Manager

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    PRIMARY DETAIL An exceptional opportunity awaits to enhance the operational efficiency of multiple chiropractic clinics. THE ROLE Salary Package: Pro-rata $74,062 - $79,823 (HEW 4), plus 17% employer's superannuation and annual leave loading Appointment Type: Part Time, 4 days per week, continuing role This position plays a vital role in ensuring the smooth...

  • Clinical Operations Coordinator

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    About the RoleThe Clinical Operations Coordinator will contribute to the effective and efficient operation of the three chiropractic clinics at Macquarie University. This role will be responsible for managing supplies, IT, and general maintenance. The successful candidate will have experience working in a clinical reception, standardising procedures, and in...

  • Clinical Translational Research Coordinator

    6 hours ago

    North Adelaide, South Australia Vanderbilt University Medical Center Full time

    Job SummaryVanderbilt University Medical Center is seeking a highly skilled Clinical Translational Research Coordinator to join our team. As a key member of our research team, you will be responsible for coordinating the approval processes and conduct of research protocols, ensuring the integrity and quality of clinical/translational...

  • Clinical Psychology Placement Supervisor

    4 hours ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    Opportunity to Supervise Students in Clinical Psychology ProgramMacquarie University Psychology Clinic is seeking a qualified psychologist to supervise students in the Masters of Clinical Psychology program. The role involves supervising students as they conduct psychometric assessments, group work, and therapy cases.About the RoleSalary Package: From...

  • Postdoctoral Researcher in Biomedical Innovation

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    PRIMARY DETAILS • Expand your professional network and enhance your career • Access state-of-the-art facilities and advanced technology • Competitive remuneration and benefits package POSITION OVERVIEW An exceptional opportunity is available for a researcher within the School of Natural Sciences. We are looking for a qualified Postdoctoral...

  • Synthetic Biology Research Fellow

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    PRIMARY DETAILS • Expand your professional network and enhance your career prospects • Utilize state-of-the-art facilities and advanced technologies • Attractive salary and comprehensive benefits package POSITION OVERVIEW An exceptional opportunity is available for a researcher within the School of Natural Sciences at Macquarie University. We...

  • Clinical Psychology Placement Supervisor

    3 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    About the RoleMacquarie University is seeking a qualified psychologist to join its team as a Clinical Psychology Placement Supervisor. The successful applicant will be responsible for supervising students enrolled in the Masters of Clinical Psychology program, providing training and mentoring to psychologists in training.Key ResponsibilitiesSupervise...

  • Clinical Psychology Placement Supervisor

    7 days ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    About the RoleMacquarie University is seeking a qualified psychologist to join its team as a Clinical Psychology Placement Supervisor. The successful applicant will be responsible for supervising students enrolled in the Masters of Clinical Psychology program, providing training and mentoring to psychologists in training.Key ResponsibilitiesSupervise...