Clinical Trials Pharmacy Technician

Job Description
The post holder will store, account and dispense Investigational Medicinal Products(IMPs) and other concomitant medications in accordance to Clinical Trial protocols and Local  MLW pharmacy MLW SOPs. He/She will reconciling key regulatory documents and pharmacy files for the Clinical Trials and ensure a coordinated implementation and closure of Clinical Trial protocols according to study specific and/or MLW  Generic Pharmacy SOPs.. He/she will be responsible for conducting audits and ensuring quality, in compliance with and collaborating with funders and LSTM. He/She will be familiar with Malawian Legislation pertaining to management of Clinical research investigational medicinal products. The post holder will be registered with the PMRA.

Responsibilities
Pharmacy

Secure storage of IMPs in accordance with Clinical Trial protocols and in monitored environment.
Checking/verifying prescriptions and dispending IMPs accordingly.
Giving advice on correct use of medicinal products including dosage and risks.
Maintain accurate accountability records
Reconciliation of IMPs in MLW pharmacy stock and returned by participants/Clinical Trial representatives
Allow pharmacy quality assurance and control activities by CRSU, Sponsor monitors and auditors, Regulatory authority and ethics committees during monitoring, audits or inspections.
Code breaking in emergency situations.
Training of study team(s) and MLW staff in pharmaceutical aspects of trial.
Recording temperature of IMP storage facilities, reviewing and maintaining electronic temperature records.
Maintaining vaccines and other temperature sensitive products under cold chain conditions, including conditioning of cool boxes.
Ensuring regular servicing of Temperature regulating devices and performance verification of temperature monitoring devices.
Ordering and controlling stock and other pharmacy supplies.
Coordinate the destruction of returned and unused expired IMPs.
Assistance in resolving data queries.
Archiving of trial information in accordance with legal required.
Maintaining a safe and clean pharmacy in accordance with MLW Generic pharmacy SOP.
Maintain proper storage and security for IMPs.
Conducting monthly inventory for IMPs and concomitant medications.

AdministrativeAttending team meetings
Completing reports including incident reports where necessary
Attending teleconferences
Disseminating new information related to the pharmacy unit to researchers and senior managers
Training

Providing training on IMP and concomitant medication handling to research staff.
Maintaining professional development.
Attending Good Clinical Practice (GCP) and Human Subject Protection training and refresher courses.
Attend Clinical Trial specific protocol trainings.
HEALTH & SAFETY

To take full responsibility for ensuring a safe work environment for the pharmacy by following health and safety rules at all times for colleagues, study participants and oneself and maintaining awareness of Health and Safety issues, for example by attending scheduled refresher meeting.

All staff are employed under the MLW Programme and are ultimately responsible to the Programme whether directly employed under the core grant, a research fellowship or project grant. All staff are expected to be flexible and may be required to contribute to the activities of the Core Programme or another project
Requirements
Diploma in pharmacy, PMRA practising licence

Other key skills and competences

Dispensing kills
Drug reconstitution skills
Proven experience in dealing with local drug regulatory authorities and oversight of pharmacy in Clinical Trials in accordance with Local Standard Operating Procedures(SOPs).
Excellent writing and computer operating skills (including MS Word, Access, Publisher and Excel)
Excellent interpersonal skills
Should be a fast learner
GCP certificate will be an added advantage.
Remuneration and Benefits

MLW offers an attractive remuneration package which includes a competitive salary package commensurate with the position, a medical aid scheme, 24 hours insurance cover, pension scheme, gratuity benefits redeemable once every year, among others. MLW also offers opportunities such as scholarships, upgrading and training opportunities to employees. These are based on successful on job performance and other set criteria.

MLW recognizes its responsibility in safeguarding and protecting communities, research participants and patients with whom MLW is working. Please note that successful candidates will be requested to undergo a safeguarding check prior to appointment and at regular time points during employment.

Suitably qualified candidates should forward their applications with copies of relevant certificates, 3 contactable referees and a detailed CV to this email [email protected]

The Human Resource Manager

Malawi-Liverpool –Wellcome Trust

P.O. Box 30096

Chichiri

Blantyre 3

To arrive no later than the 16th November, 2021, only short-listed candidates will be acknowledged.