Pharmacy IMP Administration Assistant

Job Title: Pharmacy IMP Administration Assistant

Location: London Bridge SE1 (Onsite)

Term: Permanent Full Time

Salary: Competitive Benefits (Private Medical Private Dental Life Assurance Private Pension & many more)

Provide practical hands-on support across Richmond Pharmacologys marketing activities. This role is responsible for the execution of day-to-day tasks that ensure marketing campaigns events and communications run smoothly. The role also supports practical reputation management through updates to internal systems digital channels and communication tools.

Purpose of the job

To prepare coordinate and administer unblinded investigational medicinal product (IMP) dosing activities for clinical trial participants including IMP infusions where required while maintaining strict blinding controls to ensure blinded clinical staff remain unaware of treatment allocation throughout the study.

The role is primarily focused on unblinded dosing support and safe timely dosing delivery. It also includes broader pharmacy operational support for investigational and non-investigational medicinal products including receipt storage dispensing reconciliation documentation stock control audit readiness and maintenance of pharmacy records in accordance with GMP GCP company SOPs and study-specific requirements.

Main duties and responsibilities

• Prepare and administer IMP infusions and other assigned dosing activitiesin accordance withthe study protocol pharmacyinstructionsand applicable regulatory requirements.
• Act as an unblinded member of the study team where required by the study blinding plan ensuring treatment allocation is protected and blinded study personnel are not exposed to unblinded information.
• Prime infusion lines set up infusion pumps connect infusion lines manage infusion issues perform post-infusion flushing and disconnect infusion lines where trained and delegated to do so.
• Manage and coordinate dosing times liaising with clinical teams and Research Physicians to ensureaccurateandtimelyparticipant dosing whilemaintainingblinding controls.
• Support the Research Physician during dosing procedures and provide immediate practical support during participant dosing periods.
• Accurately document all dosing activities in source documents studyworksheetsand relevant trial systems ensuring entries are completecontemporaneousand attributable.
• Review the Volunteer Database trialscheduleand pharmacy schedule in preparation for upcoming studies and daily dosing activities.
• Communicate effectively with Pharmacy Clinical Operations and ward teamsregardingdosing schedules and participant flow withoutdisclosingunblinded information.
• Be present as Immediate Life Support safety cover while participants are in the unit where trained and required by study or operational arrangements.
• Receive store handle label prepare and dispose of IMPs and NIMPsin accordance withGMP GCP company SOPs and study-specific requirements.
• Support the preparation and dispensing of sterile and non-sterile trial medication under the supervision of senior Pharmacy personnel asappropriate totraining and competence.
• Maintainaccurateaccountability records including drug logs study folders reconciliation documents environmentalrecordsand pharmacy databases.
• Support inventory control stock checks procurement of trial supplies and consumables and general pharmacy set-up activities tomaintaincontinuity of service.
• Assist with IMP returnsdestructionand reconciliation ensuring all related documentation is completed accurately andretainedappropriately.
• Contribute to the maintenance of the Pharmaceutical Quality Management System including supporting SOP and documentation updates audit preparationmonitorvisits and regulatory inspections.
• Assistwith the maintenance calibration and qualification of pharmacy premises and equipmentin accordance withapproved schedules and pharmacy procedures.
• Maintainthe clinical ward space used for dosing to a high standard ensuring itremainsclean safeorganisedand appropriately stocked.
• Resolve or escalate data queries and dosing-related issues raised by Clinical Compliance ExternalMonitorsor other stakeholders.
• Maintain the Pharmacy generic email inbox and respond or escalate queries ina timelyand professional manner.
• Participate in weekend bankholidayand shift work as required by the pharmacy rota and service needs.
• Undertake any other duties consistent with the level of the post as directed by the Head of Pharmacy or other senior Pharmacy personnel.

Skills and Experience

• BSc degree in Life Sciences Pharmacy Pharmaceutical Sciences or a related discipline or equivalent experience/knowledge.
  
• Basic understanding of regulatory compliance documentation
  standards
  and Good Clinical Practice / Good Manufacturing Practice principles.
• Current training and competency relevant to the role including study- and task-specific training before undertaking delegated duties.
  
• Experience in a pharmacy clinicalresearch or other regulated healthcare setting.
• Practical understanding of clinical trial dosing activities and/or medication handling
  

Application:

If you are interested in the role please register your details including a copy of your CV. Please note while we try to respond to every candidate the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.

Required Experience:

Junior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1