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Clinical Trial Administrator Job Description: Responsibilities, Skills, and Requirements, Study notes of Logistics

A detailed job description for a clinical trial administrator position at vaccitech. The role involves assisting with clinical activities to support research and development projects, managing essential clinical trial documents, coordinating investigator meetings, and ensuring compliance with sops, ich/gcp guidelines, and local regulations. Key responsibilities include preparing clinical trial documents, tracking and distributing documents, maintaining electronic files, arranging meetings, managing trial supplies, and facilitating ethics and regulatory submissions. The successful candidate should have experience in a clinical research environment, an understanding of regulatory and gcp activities, and excellent organizational and communication skills.

What you will learn

  • What are the duties involved in managing clinical trial documents?
  • What qualifications and skills are required for a Clinical Trial Administrator role?
  • What are the key responsibilities of a Clinical Trial Administrator?

Typology: Study notes

2021/2022

Uploaded on 09/12/2022

kaety
kaety 🇬🇧

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Clinical Trial Administrator
Reports To:
Clinical Operations Head
Location:
Office based in Oxford
Main purpose of job:
To assist with the clinical activities to support the Vaccitech portfolio of research and development
projects. All activities carried out with regard to time, cost and quality and in accordance with
SOPs, ICH/ GCP guidelines and local regulations.
Key responsibilities include:
Preparing essential clinical trial documents
Tracking, distributing and filing documents when they are returned
Maintaining the electronic Sponsor Oversight File and/or the Trial Master File (TMF)
Preparing and sending study materials to investigator sites
Management of key study related meetings including; agenda preparation, arranging
meeting logistics and taking of and distribution of minutes
Arranging investigator meetings
Tracking and processing investigator site payments
Raising purchase orders to pay investigator sites
Supporting clinical research staff within the department
Coordination of the translation of key patient facing documents
Managing trial supplies
Facilitating coordination of ethics, country-specific regulatory and research and
development (R&D) submissions
Initial composition of Investigator Site File (ISF)
Creating and maintaining study contact lists for study team and sites
Setting up mail merges
Archiving documents
Sending study newsletters to sites
Assisting with the management of safety including SUSAR reporting
Organising accommodation and flights regarding IM meetings, site visits etc
Understanding of trackers and formulas
Quality checking CRO eTMF systems and flagging any findings to the relevant person
Personal Abilities and Traits:
Demonstrates personal drive and goal orientation.
Self-motivated taking personal pride in delivering on personal and corporate objectives.
Enthusiastic and flexible to change.
Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
Able to interact with individuals at all levels of the organisation.
A highly effective communicator, both orally and in writing with an eye for detail/ accuracy
Reliable and trustworthy, able to work with minimal supervision.
Ability to work well on own as well as being part of the team
pf2

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Clinical Trial Administrator

Reports To: Clinical Operations Head Location: Office based in Oxford Main purpose of job: To assist with the clinical activities to support the Vaccitech portfolio of research and development projects. All activities carried out with regard to time, cost and quality and in accordance with SOPs, ICH/ GCP guidelines and local regulations. Key responsibilities include:

  • Preparing essential clinical trial documents
  • Tracking, distributing and filing documents when they are returned
  • Maintaining the electronic Sponsor Oversight File and/or the Trial Master File (TMF)
  • Preparing and sending study materials to investigator sites
  • Management of key study related meetings including; agenda preparation, arranging meeting logistics and taking of and distribution of minutes
  • Arranging investigator meetings
  • Tracking and processing investigator site payments
  • Raising purchase orders to pay investigator sites
  • Supporting clinical research staff within the department
  • Coordination of the translation of key patient facing documents
  • Managing trial supplies
  • Facilitating coordination of ethics, country-specific regulatory and research and development (R&D) submissions
  • Initial composition of Investigator Site File (ISF)
  • Creating and maintaining study contact lists for study team and sites
  • Setting up mail merges
  • Archiving documents
  • Sending study newsletters to sites
  • Assisting with the management of safety including SUSAR reporting
  • Organising accommodation and flights regarding IM meetings, site visits etc
  • Understanding of trackers and formulas
  • Quality checking CRO eTMF systems and flagging any findings to the relevant person Personal Abilities and Traits:
  • Demonstrates personal drive and goal orientation.
  • Self-motivated taking personal pride in delivering on personal and corporate objectives.
  • Enthusiastic and flexible to change.
  • Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
  • Able to interact with individuals at all levels of the organisation.
  • A highly effective communicator, both orally and in writing with an eye for detail/ accuracy
  • Reliable and trustworthy, able to work with minimal supervision.
  • Ability to work well on own as well as being part of the team

Clinical Trial Administrator

Essential Knowledge, experience and skills:

  • Two years’ experience in clinical research environment
  • An understanding of regulatory and GCP activities
  • Experience in working with multiple vendors including CRO’s
  • Ability to work in a small matrix team
  • Proven exceptional time management and organisational abilities
  • Ability to work effectively with cross-functional teams in multiple locations
  • Demonstrable ability to work proactively and independently
  • Attention to detail
  • Methodical approach to work
  • Computer literacy including knowledge of MS Office Desired skills:
  • Experience in early phase (I-II) studies
  • Excellent writing skills
  • Presentation skills for e.g., Investigator Meetings
  • Working with GMO experience
  • CRA/monitoring experience
  • Experience of EDC and eTMF; comfortable with electronic systems e.g. CTMS
  • Infectious Diseases and Oncology experience Please, include a CV and covering letter outlining your suitability for the role in your application.