STUDY COORDINATOR (1)

General Summary

We are seeking a highly organized, detail-oriented Study Coordinator to join our clinical trials site team. In this role, you will manage the daily operations of an upcoming phase III clinical trial for an investigational vaccine. You will serve as the primary operational link between study participants, the Principal Investigator (PI), the study team, and the sponsor. The ideal candidate has strong clinical trial experience, a thorough understanding of Good Clinical Practice (GCP), and a solid baseline background in managing complex handling protocols for biological or temperature-sensitive assets.

Key Responsibilities

  • Participant Recruitment & Enrollment: Screen electronic medical records to identify potentially eligible trial participants based on strict inclusion/exclusion criteria. Coordinate pre-screening outreach and manage high-volume scheduling for multiple patient cohorts.
  • Informed Consent Support: Assist the Investigators during the informed consent process, ensuring all participants comprehensively understand the trial milestones, risks, benefits, and safety requirements.
  • Study Visit Coordination: Schedule and execute participant visits strictly according to the protocol timeline (e.g., baseline, dosing day, and follow-up).
  • Data Collection & Management: Accurately document all participant data in Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Query and resolve data discrepancies in a timely manner to maintain sponsor data integrity deadlines.
  • Investigational Product (IP) Logistical Oversight: Collaborate with the research pharmacy to ensure proper handling, tracking, and compliance of the temperature-sensitive vaccine candidate (e.g., cold chain storage requirements).
  • Specimen Logistics Coordination: Oversee the exact collection, labeling, processing (e.g., aliquoting serum/plasma via manual or automated instruments), and rapid domestic/international shipping of biospecimens.
  • Safety Reporting Compliance: Monitor participants for post-injection reactions, local reactogenicity, and unexpected changes in health status. Immediately track, log, and escalate Adverse Events (AEs) and Serious Adverse Events (SAEs) to the PI, internal medical monitors, and sponsor safety teams.
  • Regulatory & Audit Preparation: Maintain an immaculate, audit-ready Investigator Site File (ISF). Prepare for routine monitoring visits conducted by the sponsor's Clinical Research Associates (CRAs)

Academic Qualifications

  • Bachelor’s degree in Medicine, Nursing, Public Health, Healthcare Administration, or an equivalent health-related discipline.

Person Specification

  • Education: Bachelor’s degree in Medicine, Nursing, Public Health, Healthcare Administration, or an equivalent health-related discipline.
  • Experience: Minimum of 2–3 years of Clinical trial coordination experience, ideally with previous exposure to managing vaccine, immunology, or infectious disease protocols.
  • Certifications: Active Good Clinical Practice and responsible conduct of research and Human Subjects Protection
  • Technical Skills: Proficiency with Electronic Data Capture software (e.g., Medidata Rave, Oracle Clinical) and Electronic Medical Records (EMR) systems (e.g., Epic, Cerner).
  • Direct hands-on experience handling cold-chain biological logistics or managing interactive e-diaries (used by vaccine trial participants to log daily symptoms).
  • Core Competencies
  • Attention to Detail: Absolute precision in capturing vitals, medication changes, and lab processing steps where small deviations compromise study data validity.
  • Communication: Exceptional interpersonal skills tailored for communicating complex medical study components clearly to diverse participant groups.
  • Time Management: Ability to manage rapidly shifting priorities across large patient cohorts while adhering strictly to time-sensitive protocol window requirements.


More Details
SCD001
1
IDI Mulago
Full-time
1 Years
SENIOR RESEARCH MANAGER
2026-11-04 12:28:02.000







SENIOR RESEARCH MANAGER


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We are seeking a highly organized, detail-oriented Study Coordinator to join our clinical trials site team. In this role, you will manage the daily operations of an upcoming phase III clinical trial for an investigational vaccine. You will serve as the primary operational link between study participants, the Principal Investigator (PI), the study team, and the sponsor. The ideal candidate has strong clinical trial experience, a thorough understanding of Good Clinical Practice (GCP), and a solid baseline background in managing complex handling protocols for biological or temperature-sensitive assets.

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1. About O.R. TAMBO AFRICA RESEARCH CHAIR INITIATIVE 

The Strengthening Neuro-Infectious Disease Research Capacity at Makerere University through Tiered Mentorship and Institutional Collaboration project funded through the O.R. TAMBO AFRICA RESEARCH CHAIR INITIATIVE (ORTARCHI) at the Infectious Diseases Institute (IDI), Makerere University, invites applications for fully-funded training scholarships in infectious and neurological diseases research for academic year 2026/2027.

2. Program Overview

This training program is a collaborative between Makerere University, Mbarara University of Science & Technology (MUST), University of Minnesota (USA) and Centre for the AIDS Programme of Research in South Africa (CAPRISA). The program provides multidisciplinary research training in Immunology, Epidemiology, Biostatistics, Pharmacology and Quality Improvement. Trainees will conduct research using existing neuro-infectious disease platforms or other related areas, under expert mentorship. Additionally, the program aims to establish an Infectious Disease Fellowship within the Department of Medicine at Makerere University. This will contribute to building a local and regional workforce of infectious disease specialists.

3. Background

Infectious and neglected tropical diseases remain a leading cause of death in Africa. Neuro-infections such as meningitis, encephalitis, and meningoencephalitis account for a large portion of neurological disease burden especially among immunocompromised individuals, including those living with HIV/AIDS.

In Sub-Saharan Africa:

  • Cryptococcal meningitis causes 15–19% of AIDS-related deaths.
  • TB meningitis is the deadliest form of TB.
  • CNS infections account for 12% of medical admissions in Uganda's national referral hospital, yet most etiologies remain undiagnosed.

Despite the magnitude of this problem, neuro-infections remain under-researched and under-diagnosed, leading to delayed treatment and preventable deaths.

4. Program Goal

The program aims to train and retain a new generation of African physician-scientists who will contribute to human and institutional capacity development in prevention, treatment, and research of infectious diseases. It targets highly motivated individuals committed to advancing careers in infectious diseases, with a specific focus on infectious and neurological diseases.

5. Position: MMed Scholar (5 vacancies at MakCHS and MUST)

  • 1 Position MMed Paediatrics at MakCHS
  • 2 Positions at MMed Internal Medicine at MakCHS
  • 2 Positions at MMed Internal at Mbarara University (MUST)

Eligibility:

  • Currently enrolled in second year of the MMed Internal Medicine or Paediatrics programs at Makerere or MMed Internal Medicine at MUST
  • Commitment to completing the program full-time

1. About O.R. TAMBO AFRICA RESEARCH CHAIR INITIATIVE 

The Strengthening Neuro-Infectious Disease Research Capacity at Makerere University through Tiered Mentorship and Institutional Collaboration project funded through the O.R. TAMBO AFRICA RESEARCH CHAIR INITIATIVE (ORTARCHI) at the Infectious Diseases Institute (IDI), Makerere University, invites applications for fully-funded training scholarships in infectious and neurological diseases research for academic year 2026/2027

2. Program Overview

This training program is a collaborative between Makerere University, Mbarara University of Science & Technology (MUST), University of Minnesota (USA) and Centre for the AIDS Programme of Research in South Africa (CAPRISA). The program provides multidisciplinary research training in Immunology, Epidemiology, Biostatistics, Pharmacology and Quality Improvement. Trainees will conduct research using existing neuro-infectious disease platforms or other related areas, under expert mentorship. Additionally, the program aims to establish an Infectious Disease Fellowship within the Department of Medicine at Makerere University. This will contribute to building a local and regional workforce of infectious disease specialists.

3. Background

Infectious and neglected tropical diseases remain a leading cause of death in Africa. Neuro-infections such as meningitis, encephalitis, and meningoencephalitis account for a large portion of neurological disease burden especially among immunocompromised individuals, including those living with HIV/AIDS.

In Sub-Saharan Africa:

  • Cryptococcal meningitis causes 15–19% of AIDS-related deaths.
  • TB meningitis is the deadliest form of TB.
  • CNS infections account for 12% of medical admissions in Uganda's national referral hospital, yet most etiologies remain undiagnosed.

Despite the magnitude of this problem, neuro-infections remain under-researched and under-diagnosed, leading to delayed treatment and preventable deaths.

4. Program Goal

The program aims to train and retain a new generation of African physician-scientists who will contribute to human and institutional capacity development in prevention, treatment, and research of infectious diseases. It targets highly motivated individuals committed to advancing careers in infectious diseases, with a specific focus on infectious and neurological diseases.

5. Position: PhD Fellowship at Makerere University (1 Position – Department of Internal Medicine – MakCHS)

Eligibility:

  • Completed MMed program
  • Commitment to fellowship training over 1-2 years.

1. About O.R. TAMBO AFRICA RESEARCH CHAIR INITIATIVE 

The Strengthening Neuro-Infectious Disease Research Capacity at Makerere University through Tiered Mentorship and Institutional Collaboration project funded through the O.R. TAMBO AFRICA RESEARCH CHAIR INITIATIVE (ORTARCHI) at the Infectious Diseases Institute (IDI), Makerere University, invites applications for fully-funded training scholarships in infectious and neurological diseases research for academic year 2026/2027

2. Program Overview

This training program is a collaborative between Makerere University, Mbarara University of Science & Technology (MUST), University of Minnesota (USA) and Centre for the AIDS Programme of Research in South Africa (CAPRISA). The program provides multidisciplinary research training in Immunology, Epidemiology, Biostatistics, Pharmacology and Quality Improvement. Trainees will conduct research using existing neuro-infectious disease platforms or other related areas, under expert mentorship. Additionally, the program aims to establish an Infectious Disease Fellowship within the Department of Medicine at Makerere University. This will contribute to building a local and regional workforce of infectious disease specialists.

3. Background

Infectious and neglected tropical diseases remain a leading cause of death in Africa. Neuro-infections such as meningitis, encephalitis, and meningoencephalitis account for a large portion of neurological disease burden especially among immunocompromised individuals, including those living with HIV/AIDS.

In Sub-Saharan Africa:

  • Cryptococcal meningitis causes 15–19% of AIDS-related deaths.
  • TB meningitis is the deadliest form of TB.
  • CNS infections account for 12% of medical admissions in Uganda's national referral hospital, yet most etiologies remain undiagnosed.

Despite the magnitude of this problem, neuro-infections remain under-researched and under-diagnosed, leading to delayed treatment and preventable deaths.

4. Program Goal

The program aims to train and retain a new generation of African physician-scientists who will contribute to human and institutional capacity development in prevention, treatment, and research of infectious diseases. It targets highly motivated individuals committed to advancing careers in infectious diseases, with a specific focus on infectious and neurological diseases.

5. Position: Post-MMed Fellowship, MakCHS (1 Vacancy)

Eligibility:

  • Completed MMed program
  • Commitment to fellowship training over 1-2 years.