Senior Pharmacist Clinical Research Associate

**Position Title**:Senior Pharmacist Clinical Research Associate

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.

**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