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MRC/UVRI Uganda Research Unit on AIDS   |   Uganda   |   Log in or register to see the closing date

Study Coordinator– CHAPS Project

  • Bachelor's degree
  • Project, program management
  • Experienced (senior worker)
  • Full Time
  • Temporary
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Job Summary

To lead, support, facilitate and coordinate the conduct of studies according to Good Clinical Practice (GCP) with and under direction of the Principal Investigator (PI) for the Combined HIV Adolescent PrEP and Prevention Study (The CHAPS Trial 2)


Application letters, curriculum vitae including names, email addresses and telephone contact details of three (3) referees, plus copies of academic qualifications


Responsibilities

  1. General Administrative Duties - develops training materials and tools, trains research team and maintains documentation of training, coordinates and facilitates monitoring and auditing visits, responds to any monitoring/audit findings and implements approved recommendations.
  2. Team coordination – works in close coordination with all members of the study team to ensure the community liaison team, social scientists, laboratory scientists, clinical field team and others, as appropriate, meet regularly and work in close collaboration.
  3. Preparation of Scientific Proposal - Assists the PI in determining feasibility of conducting the study including confirmation of study population availability.
  4. Protocol Development & Review - Participates in protocol development, reviews and comprehends the protocol, attends investigator meetings, prepares ethics and regulatory submission documents, prepares other study materials e.g. informed consent document, case report forms (CRFs), enrolment logs, and drug/device accountability logs, SOPs etc, establishes and organizes study files e.g. study master file, participant files etc.
  5. Study/Trial Budget Preparation - collaborates with the PI and other appropriate persons to manage the study budget and confirms accuracy and completeness of budgeted costs.
  6. Study/Trial Conduct - reviews and understands the protocol, communicates study requirements and provides appropriate training and tools to the study team, documents date of training and signatures of study personnel trained on study specific training log, collects documents needed to initiate the study for submission from the sponsor, develops and implements recruitment strategies, conducts or participates in the informed consent process, screens participants for study eligibility, coordinates participant tests and procedures, collects data as required by the protocol, assures timely completion of CRFs, maintains study timelines, maintains adequate inventory of study supplies, performs Investigational Product (IP) accountability with support from the study pharmacist, completes study documentation and maintains study files, maintains effective and ongoing communication with sponsor, ethics and regulatory authorities, research participants and PI during the course of the study, assists PI in preparation and submission of protocol amendments to the local ethics and regulatory authorities, manages the day to day activities of the study including problem solving, communication and protocol management. Ensure timely reporting of SAEs to sponsor, ethics and other regulatory bodies.
  7. Reporting - assists PI with scientific and compliance reporting requirements in accordance with the sponsor and local ethics and regulatory guidelines.
  8. Study close-out activities - study close documentation and notifications to the study subjects, research team, and other parties, completion of outstanding monitoring findings and queries, investigational product accountability together with the study pharmacist, ensures secure storage of study documents, and contributing to research articles and reports.
  9. Any other roles as assigned by the PI


General Information

Salary rangeNot specified
Additional informationNot specified
Contract type: Temporary
Job type: Full Time
Location: Uganda
Area of work: Project, program management
Seniority: Experienced (senior worker)

Job Requirements

Required education: Bachelor's degree
Required relevant work experience: 3 years
Required skills: Budgeting, financial planning; Reporting; Data collection; Training program planning; Project implementation; Public health
Required languages: English (Spoken: fluent | Written: fluent)

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MRC/UVRI Uganda Research Unit on AIDS

Non-profit, social workCompany size: 1000+ people

The MRC/UVRI & LSHTM Uganda Research Unit is an internationally recognized center of excellence for research on HIV infection and related diseases, contributing knowledge on the evolving epidemic, the evaluation of innovative health care options, treatment and prevention, and the development of health policy and practice in Africa and worldwide.


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