Site Activation Partner I-FSP at Parexel
North Ryde, New South Wales, Australia -
Full Time


Start Date

Immediate

Expiry Date

25 Jun, 25

Salary

0.0

Posted On

25 Mar, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Clinical Site Management, Training, Regulatory Requirements, English, Document Review, Medical Terminology, Life Sciences, Right First Time, Reporting, Computer Operations, Nav, Communication Skills, Metrics

Industry

Pharmaceuticals

Description

SKILLS AND EDUCATION:

  • School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferred
  • In general, candidates for this job would hold the following levels of education/experience:
  • 2 years relevant experience in clinical site management
  • Experience in study activation and site management is an asset
  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
  • Must be fluent in English, and the regulatory language of the appointed location
  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
  • Demonstrated knowledge of global and local regulatory requirements
  • Demonstrated understanding of key operational elements of a clinical trial (e.g., study startup, conduct, close-out activities, reporting, etc.)
  • Understand the quality expectations and emphasis on right first time
  • Demonstrate compliance with all applicable company, regulatory and country requirements
  • Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
  • Proven ability to work independently and, also as a team member
  • Ability to organize tasks, time and priorities, ability to multi-task
  • Understand basic medical terminology, GCP requirements and proficient in computer operations
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
  • Required to support multi-national team members, and flexibility in working hours may be needed occasionally
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Responsibilities

POSITION PURPOSE:

  • The Site Activation Partner (SAP) is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards
  • The SAP will provide technical and logistical support to the Site Relationship Partners (SRPs) to deliver Investigator Initiation and Study Start Up

PRIMARY DUTIES:

Responsible for supporting the SRPs and investigator for Targeted Sites:

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