Senior ATO Clinical Trials & Production Services

www.findapprenticeship.service.gov.uk - Jobboard; Plymouth; On-site; GBP 30,000 - 40,000; Full time

Job summary

A healthcare organization is seeking a Senior ATO Clinical Trials & Production Services professional to prepare chemotherapy and manage clinical trial processes, ensuring compliance with Good Manufacturing Practices. The ideal candidate will have a strong background in pharmacy, excellent attention to detail, and the ability to work effectively within a multidisciplinary team. Responsibilities include preparing medicines, maintaining documentation, and assisting with stock control in a cleanroom environment.

Qualifications

• Experience in preparing chemotherapy and medicines for injection.
• Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
• Ability to work independently and as part of a team.

Responsibilities

• Prepare and prioritize cancer chemotherapy and medicines for injection.
• Maintain cleanroom standards in line with Good Manufacturing Practice.
• Assist with Clinical Trial stock control and documentation.

Skills

Good Manufacturing Practice

Attention to detail

Effective communication

Clinical trial management

Education

Degree in Pharmacy or related field

Tools

Prisym 2000 label software

Pharmacy computer systems

Job description

Senior ATO Clinical Trials & Production Services

PRIMARY DUTIES & AREAS OF RESPONSIBILITY

1. Prepare and prioritize cancer chemotherapy and medicines for injection, including GMO class 1 and 2, using laminar airflow cabinets or isolator technology, ensuring all in-process checks within the clean room environment follow good manufacturing practice.
2. Prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local trust policy, and departmental procedures.
3. Work independently in the preparation of cancer chemotherapy if necessary.
4. Follow standard operating procedures meticulously to ensure safe and efficient product manufacturing in accordance with Good Manufacturing Practice legislation and guidelines.
5. Prepare product documentation, perform calculations, and produce labels using Prisym 2000 label software.
6. Assemble raw materials and consumables for each product, ensuring segregation of preparations as per SOP.
7. Assist with Clinical Trial stock control, including routine stock checks, stock rotation, expiry date checks, and investigating discrepancies.
8. Maintain and file all relevant documents, records, and reports.
9. Clean the pharmacy aseptic suite and support rooms following SOPs, ensuring quality control and proper record-keeping.
10. Participate in training and development activities related to production services.
11. Complete environmental monitoring and validation tests as requested by the quality assurance manager.
12. Communicate effectively with R&D, research teams, multidisciplinary teams, UK organizations, and pharmaceutical companies.
13. Perform dispensary duties, including labelling, dispensing inpatient/outpatient/discharge prescriptions, and issuing drugs, including clinical trials and controlled substances.
14. Ensure accurate record-keeping of drug accountability for clinical trials and report any issues.
15. Manage stock control of clinical trial products, ensuring sufficient in-date supplies for patients.
16. Record and dispose of returned clinical trial drugs appropriately.
17. Assist with the closure and archiving of completed clinical trials.
18. Organize trial monitor visits and prepare site files and drug returns in advance.
19. Respond promptly to inquiries, directing them to the appropriate team members.
20. Use the pharmacy computer systems and related technologies as needed.
21. Participate in ordering and receipt of clinical trial products following protocols and SOPs.
22. Ensure trials adhere to GCP, GMP, and Good Dispensing Practice, reporting deviations as necessary.
23. Monitor storage conditions and expiry records for clinical trial products, maintaining compliance with GCP and GMP guidelines.
24. Maintain pharmacy trial store and equipment in good condition.
25. Attend GCP training and adhere to GCP standards at all times.
26. Participate in appraisals and mandatory training.
27. Assist with training pharmacy staff in dispensing clinical trials.
28. Participate in audit projects related to clinical trial processes.
29. Provide advice to pharmacy staff regarding clinical trials.
30. Contribute to departmental training, including NVQ Level II.
31. Adhere to SOPs and policies independently.
32. Maintain personal and professional development records.