The Joint Clinical Research Centre (JCRC) is an indigenous medical organization that was established in 1991 as a Limited Liability not-for-profit Joint-venture between the Uganda Ministry of Health (MoH), Ministry of Defense and Makerere University Medical School (now Makerere College of Health Sciences). The Centre was established to respond and provide a scientific approach to the national HIV&AIDS challenge.

Job Title: Head QA.QC/ QA.QC Manager
Reports: Director Research
Supervises: Research Monitors and QA.QC Officers

Purpose of the position;
The overall responsibility of the QA/QC Manager is to oversee the general progress of all research studies at the JCRC ensuring that they are conducted in accordance to the approved Protocols, sponsor MOPs, institutional SOPs, ICH-GCP guidelines, and applicable local laws.
Reporting line;
The QA/QC manager reports to the Director of Research.

Job responsibilities;
• The QA/QC Manager supervises the performance of all the QA/QC Officers including periodic appraisal of their work.
• Organizes and chairs quality management meetings and gives a report of all QA/QC activities to the PIs and Heads of the institution for each of the actively ongoing studies at JCRC.
• S/he also guides staff in resolving errors/omissions and ensures timely communication of quality management evaluations to the study team and keeps them informed of QA findings.
• S/he is also responsible for ensuring that all study staff have undertaken appropriate Protocol, MOP, SOP and ICH-GCP training.
• S/he also periodically makes assessments for competence evaluations and re-training of staff.
• The Quality Assurance/Quality Control Manager will also be responsible for supervising QA/QC activities for all clinical research projects. Such activities would include:
• To evaluate and verify in real time that the requirements for the quality of the trial related activities have been fulfilled.
• To ensure the trials are conducted, data is generated, documented and reported in compliance with the current approved protocols, Good Clinical Practice (GCP) and the applicable regulatory requirements.
• To ensure that all study participants have written signed consent and/or assent forms, in the most appropriate language.
• To ensure direct access to trial related sites, source documents and reports for all involved parties that secured their agreement with the CRO/institution, for the purpose of Monitoring, IRB reviews/inspections and/or Sponsor Audits.
• Ensure availability, accessibility and adequacy of study supplies and/or equipment incl. IP documentation and accountability.
• Assist Study Coordinators and the regulatory manager in ensuring that compilation and submission of the regulatory documents to the relevant Regulatory Authorities is complete.
• To ensure that the trial sites have adequate and up to date essential documentation at all times of the study execution.
• To ensure that all trial related data is accurate, consistent, reliable and has been processed correctly, ready for electronic data capture.
• To ensure that all agreements are in writing with the parties involved in the trial and that they are all adequately executed.
• To follow the institution/CRO established written SOPs as well as those procedures that are specified by the sponsor for monitoring a specific trial.
• Attend Bi-weekly departmental meetings and report (in writing) any significant findings related to the trial(s).
• To discuss any major deviations or deficiencies with the Investigator(s), Monitor(s) and Research supervisor(s) for corrective and preventive action.
• And any other duties as assigned from time to time.

Qualifications and experience;
• Bachelor’s Degree in a scientific / health related discipline. A master’s degree in these fields is an added advantage.
• Minimum of 5 years in a medical research setting and 3 years as a QA or QC officer in a clinical study environment.
• Solid understanding of GCP, GLP and ICH clinical requirements.
• Experience with both domestic and international clinical studies.
• Able to travel domestically approximately 25% of the time.
• Ability to communicate effectively in written and oral form, e.g. in designing writing memos and letters, and in discussions, negotiations and workshop settings.
• Must have attention to detail skills.
• Strong leadership skills and ability to supervise several staff.
• Proven capacity for analytical and interpretative problem anticipation and solving.