What are the responsibilities and job description for the Clinical Trial Assistant II - IQVIA MedTech position at IQVIA?
IQVIA MedTech is seeking a Clinical Trial Assistant II!
BASIC FUNCTIONS:
The primary role of the Clinical Trial Associate position is to administer, maintain, and coordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) and Process Documents (PDs) and the Study Responsibilities Task List. Will act as a pivotal point of contact and support for the Project Management team and function as a mentor/trainer for entry level staff. The Sr. Clinical Trial Associate may travel up to 30% to Project Management Team meetings or for other business-related reasons.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies.
- Prepare, collect and provide support to sites on essential document collection and maintenance.
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper).
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File.
- Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions.
- Assist Clinical Trial Manager (CTM) with development of Informed Consent Form Template (ICF).
- Coordinate with Recruitment Management regarding advertising submissions to IRB.
- Prepare Drug Release Authorization forms and collect required documentation.
- Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF.
- Assist CTM with tracking of clinical trial agreements (CTA) with Investigator Sites.
- Prepare and coordinate materials (e.g. binders, agendas, meeting minutes, slide presentations) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF).
- Perform data entry into electronic systems (i.e. CTMS) for study or client information.
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Communicate with sites on issues escalated by a monitor and/or the CRA Manager.
- Train entry level personnel Clinical Trial Associate (CTA) I and/or Project Assistant (PA)
- Perform administrative tasks to support team members with clinical trial execution as needed.
KNOWLEDGE, SKILLS AND ABILITIES:
- General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority.
- Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Strong written and verbal communication skills.
- Effective time management and organizational skills.
- Attention to detail and accuracy in work
- Aptitude for handling and proofreading data.
- Strong customer service orientation.
- Ability to function as a trainer/mentor for entry level staff.
- Ability to function independently with minimal supervision
- Ability to travel (e.g., Investigators Meetings)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very little physical effort required to perform normal job duties (unless otherwise indicated)
MINIMUM RECRUITMENT STANDARDS:
College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) with related work experience.
Or
= 3 years' experience at Novella Clinical in a project team position or working within the health sciences field in a similar position.
#LI-BNEGRON
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
BASIC FUNCTIONS:
The primary role of the Clinical Trial Associate position is to administer, maintain, and coordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) and Process Documents (PDs) and the Study Responsibilities Task List. Will act as a pivotal point of contact and support for the Project Management team and function as a mentor/trainer for entry level staff. The Sr. Clinical Trial Associate may travel up to 30% to Project Management Team meetings or for other business-related reasons.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies.
- Prepare, collect and provide support to sites on essential document collection and maintenance.
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper).
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File.
- Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions.
- Assist Clinical Trial Manager (CTM) with development of Informed Consent Form Template (ICF).
- Coordinate with Recruitment Management regarding advertising submissions to IRB.
- Prepare Drug Release Authorization forms and collect required documentation.
- Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF.
- Assist CTM with tracking of clinical trial agreements (CTA) with Investigator Sites.
- Prepare and coordinate materials (e.g. binders, agendas, meeting minutes, slide presentations) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF).
- Perform data entry into electronic systems (i.e. CTMS) for study or client information.
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Communicate with sites on issues escalated by a monitor and/or the CRA Manager.
- Train entry level personnel Clinical Trial Associate (CTA) I and/or Project Assistant (PA)
- Perform administrative tasks to support team members with clinical trial execution as needed.
KNOWLEDGE, SKILLS AND ABILITIES:
- General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority.
- Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Strong written and verbal communication skills.
- Effective time management and organizational skills.
- Attention to detail and accuracy in work
- Aptitude for handling and proofreading data.
- Strong customer service orientation.
- Ability to function as a trainer/mentor for entry level staff.
- Ability to function independently with minimal supervision
- Ability to travel (e.g., Investigators Meetings)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very little physical effort required to perform normal job duties (unless otherwise indicated)
MINIMUM RECRUITMENT STANDARDS:
College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) with related work experience.
Or
= 3 years' experience at Novella Clinical in a project team position or working within the health sciences field in a similar position.
#LI-BNEGRON
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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