Clinical Research jobs in United States

Dueto expansion the of our service an exciting opportunity has arisen for anenthusiastic, self-motivated band 8a pharmacist to join the pharmacy ClinicalTrials Management team at Leeds Teaching Hospitals NHS Trust. Applicantsshould have an active interest in clinical trials and an understanding ofgood clinical practice (GCP).

Thisis a split post working with oncology clinical services to support their safedelivery of clinical trials, including development of chemotherapy electronictrial prescriptions . You will provide specialist oncology clinical supportas part of a wider team on a sessional basis, working closely with the teamto ensure safe and appropriate supply of medicines.

Thispost will be based at Bexley Wing but will provide support for clinicaltrials running at all 3 sites. It isan exciting time to work in research due to recent expansion of the ClinicalResearch Facilities (CRF), vaccine innovation pathway workstreams and ongoingdevelopment of a world class hub for innovation.

Youwill work closely with a number of internal and external teams includingclinical pharmacists, aseptic services, the Clinical Research Facility team,investigators and research nurses, the Trust Research & Innovation teamand pharmaceutical companies.

Lead and coordinate the localpharmacy review process for new clinical trials. To include liaising withinvestigators, trial sponsors, research networks and Trust R&I regardingany medicines management issues identified.

Provide support and advice toAdvanced Clinical Pharmacists and rotational pharmacists on the preparationof clinical trial reviews, electronic prescribing set-ups, protocolamendments and other trial related activities.

Provide expert advice andinformation in relation to all medicines related aspects of R&Iactivities within the Trust to ensure compliance with local and nationallegislation and guidelines.

Check and approve final versions ofIMP (investigational medicinal product) management procedures for individualtrials. Complete the Pharmacy review and approval process for clinical trialsin set up.

Assist in the development ofprescriptions on the chemotherapy electronic prescribing system (ChemoCare)in conjunction with the clinical cancer services pharmacists. Provideoversight of this process to ensure quality and consistency standards forclinical trial prescriptions are maintained.

Assist in the provision of trainingto pharmacy staff on Good Clinical Practice and regulatory frameworks,guidelines,

Line manage Band 7 pharmacistsworking within the Clinical Trials team.

Provide a specialised clinicalpharmacy service to a clinical area for up to 4 sessions a week.

LeedsTeaching Hospitals NHS Trust is one of the largest teaching hospitals in theUK with a large number of specialised and highly specialised services. It has an established reputation as aCentre of Excellence for delivering high quality research and innovation on alarge scale with pharmacy currently supporting over 350 clinical trialsacross all hospital sites.

Leedsis a wonderful city to work in and LTHT is an organisation that puts itspatients first and highly values and supports its staff. Pharmacy is aforward thinking department that values the contribution of all our staff andis recognised in the organisation for our collaborative working as wecontinuously support our workforce to develop to their potential indelivering the best patient care.

LeedsTeaching Hospitals is committed to our process of redeploying 'at risk'members of our existing workforce to new roles. As such, all our job advertsare subject to this policy and we reserve the right to close, delay or removeadverts while this process is completed. If you do experience a delay in theshortlisting stage of the recruitment cycle, please bear with us while thisprocess is completed, and contact the named contact if you have anyquestions.

Lead and coordinate the localpharmacy review process for new clinical trials. To include liaising withinvestigators, trial sponsors, research networks and Trust R&I regardingany medicines management issues identified.

Provide support and advice toAdvanced Clinical Pharmacists and rotational pharmacists on the preparationof clinical trial reviews, electronic prescribing set-ups, protocolamendments and other trial related activities.

Provide expert advice andinformation in relation to all medicines related aspects of R&Iactivities within the Trust to ensure compliance with local and nationallegislation and guidelines.

Review and improve currentMedicines Management and Pharmacy Services CSU (MMPS) clinical trial set-upprocesses to provide a service that meets the Trusts performance targets forinitiation and delivery of NIHR portfolio clinical trials.

Check and approve final versions ofIMP (investigational medicinal product) management procedures for individualtrials. Complete the Pharmacy review and approval process for clinical trialsin set up.

Assist in the development ofprescriptions on the chemotherapy electronic prescribing system (ChemoCare)in conjunction with the clinical cancer services pharmacists. Provideoversight of this process to ensure quality and consistency standards forclinical trial prescriptions are maintained.

Contribute to the developmentof systems to accurately recordclinical trial activity and share the output with wider MMPS teams.

Ensure that current PharmacyClinical Trial Standard Operating Procedures (SOPs) are applicable and complywith Good Clinical Practice and the requirements of the UK Clinical TrialRegulations. Write, update or amend in conjunction with the Clinical TrialsManagement Team as necessary.

Identify areas within pharmacywhere additional input is required to support clinical trial work. Contributeto business cases to support development of the service.

Assist the Clinical Trials team inpreparing for clinical trial audits and inspections by trial sponsors,pharmaceutical companies and regulatory agencies.

Assist in the provision of trainingto pharmacy staff on Good Clinical Practice and regulatory frameworks,guidelines, policies and procedures relating to clinical trials.

Line manage Band 7 pharmacistsworking within the Clinical Trials team.

Use local and national networkingopportunities to promote the LTHT clinical trials service to a wideraudience.

• UK Pharmacist registered with the General Pharmaceutical Council
• Postgraduate diploma in clinical pharmacy or equivalent
• Full GCP certificate

• Team player
• Influencing and negotiation skills
• Time management
• Leadership

• Good understanding of the application of GCP
• Advanced clinical pharmacy knowledge
• Experience working as a pharmacist in Oncology
• Chemo-care or similar electronic chemotherapy prescribing system experience

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.