CRA IMP Returns Specialist
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
- 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.
- 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.
Email Marc Joseph