CRA IMP Returns Specialist Posted By: Admin    2015-May-29

Job Background

 

My Client is a world leader in the development of non-smoked prescription medicines derived from cannabis. Their focus is to bring novel prescription medicines to market which provide patients with serious conditions with valuable medicines which make a real difference to their quality of life. Through rapid cost-effective product development, addressing market needs, and establishing commercial partnerships, they seek to maximise the value of its products and shareholder returns.

There is currently a new really exciting opportunity for a DYNAMIC home based clinical research associate to join their clinical development team. This role will focus on IMP management.

 

Duties & Responsibilities

 

Key Responsibilities

  • Ensures the integrity of clinical data in relation to IMP documentation and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with SOPs, performs site management activities pertaining to IMP accountability and return at :
    • monitoring visits
    • closeout visits
  • Collaborates with the US CRA and CPM teams to plan and schedule regular accountability and shipment of returns of a controlled IMP.
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol for IMP accountability and returns.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Requirements

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification and experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Good knowledge of relevant SOP’s, ICH-GCP, The US Food and Drug Administration FDA Code of Federal Regulations Title 21 – Food & Drugs Good Clinical Practice Parts: 11, 50, 54, 56, 312, 314 and 1308 and other regulatory guidelines, as applicable.
  • Previous experience of working with Schedule I and/or Schedule II controlled substances essential (Preferred).
  • Previous experience with shipping Dangerous Goods and current IATA Certification (Preferred).
  • Fluent in English.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail with a proven track record for ensuring quality data and good site management.
  • Ability to be available for domestic and international travel including overnight stays, as required.
  • Able to use initiative and problem solve.

Salary

On Application

Position Type

Contract
Full Time

Contact

Email Marc Joseph

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