Clinical Trial Pharmacist

Job Title: Clinical Trial Pharmacist

Duration: Permanent appointment – Full time

Professional Accountability: Matrix managed (Site manager/Operations Director)

Background

Clerkenwell Health is a contract research organisation offering clinical support services, including clinical trial design conduct and management, for psychedelic assisted therapies. We work with drug development companies that are developing psychedelic drugs to be used in the treatment of mental health and neurological disorders alongside our therapy. We have a delivery site located in central London where we will conduct our clinical trials as well as contracting partner sites to support our delivery.

At Clerkenwell Health we place a high priority on patient safety ensuring our services are adhered into this. This role will provide the key point of safeguarding investigational products for use during investigational studies and the overall management of the pharmacy function.

You will be responsible for the management of investigational products including IMP, scheduled controlled drugs, psychedelics and other pharmaceutical products.

You must participate in the feasibility of the trial at site, sit selection visit and site initiation visit. Once the trial is ready to commence, responsibilities include supply ordering, handling, storage, dispensing, accountability and destruction in accordance with the current approved trial protocol.

Why this role matters

How this role impacts others – internally and externally

This role is key to establishing a robust pharmacy service that will be utilized for the CRF and potential sites in the future

● This role will be a key driver in the processing and approval of the Home Office license to safeguard the care of IMP at site

● This role greatly impacts the ability of the site Overall IMP management and build credibility with Sponsors, CRO s and other stakeholders

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Responsibilities

Overview

· Liaising with other staff including the Chief medical Officer, PI (Principal Investigator), Sub- Investigators, Clinical Manager at site and across all Sponsors, regarding requirements for studies of Investigational Medicinal Product (IMP)/commercial and comparator.

· Ensure that documentation is completed to GCP (Good Clinical Practice) standards and maintain complete accountability of study material of pharmacy aspects and investigate any discrepancies.

· Ensure that appropriate measures are taken for the Investigational Medicinal Product / commercial and comparator are kept at the appropriate storage conditions.

· Develop pharmacy procedures: Un-blinded and blinded dispensing of medication and supply/resupply, Final check of preparation of the IMP, Documentation of storage conditions and resolve pharmacy issues for the sites.

· Investigate any temperature or other excursions regarding storage of study drug material.

· Lead in regulatory audits and client monitoring visit of the pharmacy.

· Authorise or reviewing the SOPs regarding IMP / Commercial & Comparator, when necessary.

· To contribute to strategic planning and development of pharmaceutical function and services within the CRF and adhere with overarching Clerkenwell Health strategy for expansion

· Conduct and arrange trainings for Pharmacy team including second checkers on site

· Develop and maintain a planned preventative maintenance log for the Pharmacy room keeping a record of actions taken and liaise with the service providers to ensure timely completion of all maintenance.

· Authorise timely corrective and preventative actions in the event of an adverse monitoring report.

· Welcome patients and put them at their ease, optimising patient experience. Always deal courteously with patients. Ensure a pleasant and safe environment for patients. Encourage patients to continue trials and to participate in future trials.

· Ensuring data queries are resolved in a timely manner by liaising with the data team and study monitor.

· Identify areas for improvement. Identify potential training need Compliance with Clerkenwell Health Health and Safety policy Compliance with CRF policy on equality and diversity.

· To maintain professional qualifications required for the role, including continuous personal development. To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice. To work according to company SOPs, guidelines, and policies.

· To work according to current data protection standards and practice valuable information management. Maintenance of strict confidentiality of patient and business-related data.

· To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out.

· To support the aims and represent Clerkenwell Health appropriately in a professional way to all our customers

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Requirements

Essential

· Degree in Pharmacy (Preferably M-Pharm)

· GPhC Registered

· Post qualification experience – 2 years

· Excellent communication and professional customer service approach.

· Good time management skills, attention to detail and able to work under pressure

· Willingness to work collaboratively and to value the importance of teamwork

· A flexible attitude with respect to work assignments and new learning

Desirable

· Experience of working in a clinical or scientific environment

· Experience of clinical trials, pharmacy, and IMP management

· ICH- Good Clinical Practice certification

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Compensation

● Competitive salary package - £40-44k plus performance incentives

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Essential dates

● Closing date: March 9,

● Informal chats: March 10

● Panel interview: March 15

Clerkenwell Health

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