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Kenya Medical Research Institute (KEMRI) – Study Pharmacist.

Get a free C.V. review by sending your C.V. to submitcv@careerassociated.com or click the following link. Submit C.V.! use the subject heading REVIEW.

IMPORTANT: Read the application instructions keenly, Never pay for a job interview or application.

Click the Links Below to Get Job Updates.

https://www.facebook.com/groups/1126060830815705

https://t.me/joinchat/EBWPu0Cfzh880lRySce_AQ.


Opening Date: 20th April, 2022
Background Information:

Sanofi study: A parallelgroup, Phase III, multistage, modified doubleblind, multiarmed study to assess the efficacy, safety, and immunogenicity of two SARSCoV2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID19 in adults 18 years of age and older.

We have the below vacancies in the SANOFI study.

Position: Study Pharmacist (1 Position) K MR 6 Vacancy No. FN001042022
Reports to:
Study Doctor
Location: Kisumu

Duration:
1 Year Renewable Contract as per KEMRI Scheme of Service. The first 3 months is a probation period
Qualifications:

Bachelor of Pharmacy Degree from a recognized University.
Registered with the pharmacy and poison board
Masters in Public Health will be an added advantage.

Duties and Responsibilities:

Management of regulatory affairs regarding pharmacy and enhancing communication between pharmacy and local PPB and the site.

Monitor drugs and other medical supplies levels and initiate the procurement process.

Take inventory and track medication and supply orders as well as expiries. Keep records of all drug stocks ordered, drugs issued to clients and stocks remaining

Participate in the review, planning and implementation of clinical trials. This will include the evaluation of study design, feasibility, pharmaceutical regulatory requirements, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study
Develop the text for the study product section of the protocols in cooperation with members of the protocol team and the pharmaceutical manufacturers for existing pharmaceutical products as well as new chemical entities and modalities. This includes researching and analyzing background material from Investigator’s Brochures, prescribing information, and literature reviews.
Advise the study team and leadership regarding pharmacy aspects of proposed studies
Develop protocol specific trainings for site pharmacists and clinic staff utilizing webbased systems, software, or other tools (ie., power point presentation).
Provide leadership in collaboration Project Managers for developing studyspecific blind labeling and packaging plan and strategies.
Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.
Ensure that pharmaceutical concerns are raised during meetings are addressed in a timely manner

Advise the protocol team regarding pharmaceutical issues relating to PPB standards, FDA and other Health Authorities regulations, State and incountry requirements.
Evaluate the protocol and provide leadership with estimates of study product needs and or
cost based on factors such as sample size, dose, formulati
on, strength, rate of accrual, and duration.
Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.
Generate Study Product Request Letter/ Email for studyspecific and division leadership’s review and approval.
Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
Obtain information about existing infrastructure and processes to use to evaluate pharmacy personnel and infrastructure capacity the Clinical Research Site,
Evaluate and finalize all temperature excursions that occur during shipment and at Research Pharmacy Sites in collaboration with PI and study coordinators
Receive and process product complaints with or without AES/SAEs from research site pharmacies.
Write/draft Standard Operating Procedures (SOPs) related to Pharmaceutical Services and participate in SOP review committees as needed.
Utilize pharmacy practice experience and pharmaceutical expertise in the design, review and revision of DAIT Pharmacy documents.
Participate in meetings, facetoface protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring plan as needed.
Order, receive, ship study products and maintain chain of custody of Investigational Products (Ips) purchased or received by the trial site(s).
Ensure proper storage conditions for IPs including maintaining pharmacy temperature and humidity logs
Update the database of IPs and other pharmacy products on a monthly basis. Ensuring accurate and timely records of dispensed drugs and study products on the pharmacy logs and in the accountability logs and Database.
Administer respective Case Report Forms (CRFs)

Carrying out QA/QC of study CRFs and source docs and resolve queries that may arise.

Dispensing drugs and Study products to participants.

Counselling participants on adherence to study products

Participants Randomization process in liaison with the data and clinic teams and ensure blinding.

Processing study products destruction documents and taking part in actual destruction process.

Training other staff on pharmacy protocol based procedures.

Perform projection and orders of the required drugs in liaison with the study clinicians and account for their use

Perform stock checks and share out to the prescriber.

Prepare and dispense prescribed medications and pharmaceutical preparations according to participants’ prescription.

Provide advice for nonprescription medications.

Establish and maintain good relationships with participants to foster study retention.

Prepare weekly and monthly progress reports of personal study activities

Closely work with other staff members to ensure the success of the study

Other Required Skills
Commitment to integrity and high quality performance

Good interpersonal skills and ability to work in a team

Keen and attentive to detail

Ability to follow instructions and procedures

Articulate in both verbal and written communication in English and Swahili.

Counselling skills

Good track of record keeping

Some store keeping skills

Computer literacy

How to Apply
a) All applicants must meet each selection criteria detailed in the minimum requirements.

b) Must include a current CV with names of at least three referees.

c) Must include copies of academic and professional certificates.

A duly signed application letter indicating the vacancy reference with copies of documents listed above should be sent to: hrrctp@kemrirctp.org not later than 10th May, 2022.

KEMRI IS AN EQUAL OPPORTUNITY EMPLOYER COMMITED TO DIVERSITY;PERSONS WITH DISABILITY, WOMEN, YOUTH AND THOSE FROM
MARGINALIZED AREAS ARE ENCOURAGED TO APPLY.

Only shortlisted candidates will be contact
ed.

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