Job Description
Position Title: Senior Pharmacist Clinical Research Associate
Position Purpose:
The purpose of the position is to assist in/ is responsible for ensuring the efficient and effective management of Investigational Product at sites in Africa, ensuring that the site pharmacies are equipped to conduct rigorous clinical trials. This includes effective project and quality management, communicating effectively with diverse stakeholders, production of training and study-specific materials, site assessments and monitoring, developing and driving timelines and adjusting expectations as necessary.
Senior Pharmacy or IP-related issues or challenges that arise in the implementation of
projects/studies are fielded by the Senior Pharmacist in collaboration with the Sr Projects
Manager, and soliciting assistance from other stakeholders, as appropriate.
Works to carry out the operational strategy of the Network. Regularly interacts with HVTN LOC staff and functional groups, Sponsor staff and regional CRS investigators and staff to provide support, particularly as relates to IP logistics and management and pharmacy /site operational issues in the implementation of study protocols. Works with other staff to develop, implement, conduct and audit the spectrum of quality assurance, regulatory, and compliance activities for clinical trials and ancillary studies.
Reporting to: Senior Project Manager
KEY RESPONSIBILITIES
• Act as primary liaison for any pharmacy-related issues pertaining to allocated study with HVTN Programme/Project Manager and site. Serve as the primary liaison to site pharmacists.
• Provide support in international and local Study Product shipment and distribution, including reviews, paperwork, packaging and labelling advice.
• Interface/communicate with Protocol Pharmacist, study Sponsor and Site Pharmacists on all matters related to Study Product orders and shipments.
• Review, monitor and process protocol-related site orders from initiation through to delivery and receipt.
• Monitor Study Product stock levels and expiry at depot and sites.
• Ensure appropriate ordering, receipt, return and destruction/disposal of Study Product in accordance with specific Sponsor and other requirements, including accurate and timeous documentation of the processes by sites.
• Assist Protocol Pharmacist with Regulatory and Quality Assurance including SOPs, WPGs, self-audits, complaints and Deviation Reporting.
• Assist in the evaluation of site pharmacy infrastructure, personnel and processes, maintaining continuous communication with site pharmacists to obtain information and clarity needed for final review and approval.
• Participate in the review, planning and implementation of new and amended protocols including feasibility, estimation of supply quantities and other requirements when needed.
• Develop/design, review and revise protocol/project-specific pharmacy guidelines/
manuals/procedures/tools/forms or other project materials in accordance with Sponsor/Project requirements.
• Conduct and report on site visits as required including unblinded monitoring visits, support/assessment visits, for cause, Study Product destruction preparation and witnessing. Provide input on site pharmacy prioritization for Monitoring.
• Utilize pharmacy practice experience and pharmaceutical expertise in the preparation, review and revision of documents, tools and materials. Draw on knowledge of and relationships with sites' operations in the assessment of sites.
• Act as primary liaison for any pharmacy-related issues pertaining to allocated study with HVTN Programme/Project Manager and site. Serve as the primary liaison to site pharmacists.
• Provide support in international and local Study Product shipment and distribution, including reviews, paperwork, packaging and labelling advice.
• Interface/communicate with Protocol Pharmacist, study Sponsor and Site Pharmacists on all matters related to Study Product orders and shipments.
• Review, monitor and process protocol-related site orders from initiation through to delivery and receipt.
• Monitor Study Product stock levels and expiry at depot and sites.
• Ensure appropriate ordering, receipt, return and destruction/disposal of Study Product in accordance with specific Sponsor and other requirements, including accurate and timeous documentation of the processes by sites.
• Assist Protocol Pharmacist with Regulatory and Quality Assurance including SOPs, WPGs, self-audits, complaints and Deviation Reporting.
• Assist in the evaluation of site pharmacy infrastructure, personnel and processes, maintaining continuous communication with site pharmacists to obtain information and clarity needed for final review and approval.
• Participate in the review, planning and implementation of new and amended protocols including feasibility, estimation of supply quantities and other requirements when needed.
• Develop/design, review and revise protocol/project-specific pharmacy guidelines/
manuals/procedures/tools/forms or other project materials in accordance with Sponsor/Project requirements.
• Conduct and report on site visits as required including unblinded monitoring visits, support/assessment visits, for cause, Study Product destruction preparation and witnessing. Provide input on site pharmacy prioritization for Monitoring.
• Utilize pharmacy practice experience and pharmaceutical expertise in the preparation, review and revision of documents, tools and materials. Draw on knowledge of and relationships with sites' operations in the assessment of sites.
EDUCATION, CERTIFICATION, QUALIFICATIONS AND EXPERIENCE NEEDED
• Minimum Life Science degree or equivalent required. Pharmacy background preferred.
• 3-7 years of clinical trial monitoring or quality assurance/ management experience. Experience with trials set in Sub-Saharan Africa with US sponsors desirable.
• Relevant project/study/research management.
• An equivalent combination of education and experience may be accepted.
• Experience working in a team with a wide range of education and experience.
• Understanding of clinical trial conduct in limited resource settings.
• Ability to identify and communicate trial conduct issues and facilitate resolution between research collaborators and study sites quickly and effectively, with issue escalation when appropriate.
• Capable of establishing priorities and managing multiple concurrent projects to meet project timelines.
• Familiar with xGCP, GPP regulations and other industry standards as they relate to clinical trials.
COMPETENCIES /SKILLS/ KNOWLEDGE
• Highly motivated, self-starter, fast learner and able to work independently.
• Ability to work well with colleagues and as part of a team.
• Ability to work under pressure.
• Strong analytical skills and attention to detail.
• Excellent written and verbal communication skills.
• Excellent reporting and presentation skills
• Proficiency in standard business productivity software, including MS Office, web-based and teleconferencing platforms.
• Flexibility and willingness to travel as required. This position may require collaboration with colleagues in various time zones and as such work outside of normal regional business hours.
Should you be interested in applying for this vacancy, submit your application online: https://southafrica-fhcrc.icims.com/jobs/search5770326
Closing date: 12 August 2022
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