Senior Clinical Research Coordinator/Lab Manager

Job Summary

The Association of Anesthesiologists of Uganda (AAU) along with the University of California San Francisco’s (UCSF) Center for Health Equity in Surgery and Anesthesia are launching the first research and development laboratory in Uganda. This laboratory will work with researchers, regulatory bodies and device manufacturers to evaluate the performance of medical devices such as pulse oximeters in healthy human subjects. The laboratory is seeking a Senior Clinical Research Coordinator/Lab Manager (final title will be determined based on experience level).

This position will independently coordinate and be accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel.

The position is responsible for, and critically important to the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials, local investigator-initiated clinical trials, and/or programmatic clinical research activities. This position may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people at the AAU, UCSF, Makerere University, and Busitema University (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (international industry sponsors, coordinating centers), exhibiting an in-depth knowledge of specific programs.

Reporting to the Co-Principal Investigators, the incumbent may have central responsibility for ensuring subject recruitment, appropriate study testing, and adequate enrollment of studies, exercise strong administration and management leadership of research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities

% of time	Key Responsibilities (To be completed by Supervisor)
20%	Research Operations Management: Develop project plans, interview key sponsors, and deliver tangible project results Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables Design and perform ad-hoc performance analysis of the projects and the project staff Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects Perform business process review, operational reviews and design and implement workflow and controls Develop project-related presentation material for study Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)
40%	Clinical Trials Management: Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance. Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects’ options, and ensure that documentation and storage of study files meets legal requirements. Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all ethical approvals are up to date. Oversee preparation of new ethical approval applications; arrange paperwork for renewal of existing protocols; respond to requests for revisions; and coordinate protocol changes with study sponsors. Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the ethics committee in a timely manner. Respond to requests and reviews of studies from sponsors, study monitors, regulators, and other entities
10%	Risk Management: Protect the laboratory from non-compliance and potential litigation by ensuring contract compliance, meeting local laws, and ensuring compliance with hiring and supervision laws; implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success. Act as regulatory authority and advisor by training and educating employees and advising leadership and PI’s. Manage audits. Help institute and maintain a Quality Improvement Process.
10%	HR Management/Administration: Recruit and train clinical research coordinators in collaboration with leadership. Mentor clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry. Train in national and local research laws and guidelines. Help manage personnel needs.
20%	Financial Management: Oversee budgets, invoices, and reimbursements. Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients. Guide subjects through financial process (private vs. federal trials and their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible Review budget reports on a monthly basis. Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds. Responsible for ensuring that the use of research funding is in compliance with funding agency protocols. Assist PI in grant development, focusing on budget development.
100%

Required Qualifications:

A degree in Health Sciences, Nursing, Clinical Research, Public Health, or a related field.
Minimum 3 years experience in clinical research coordination or project management.
Experience with drafting, submitting, or revising local REC/IRB approvals including with the UNCST
Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, regulations, and complex visit structures.
Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.
Ability to analyze complex and non-routine issues requiring innovative solutions.
Ability to operate effectively in a changing organizational and technological environment.
Ability to develop project plans/schedules and motivate teams to meet deadlines.
Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and management of budgets.
Experience managing grants, subawards and contracts with international organizations
Experience using database software, such REDCap and Qualtrics
Based in Kampala and able to work on site 5 days per week

Additional (Desired) Qualifications

A masters degree in Health Sciences, Nursing, Clinical Research, Public Health, or a related field.
Prior experience with device or physiological monitoring studies.
Familiarity with Uganda’s research and regulatory environment (e.g.,UNBS, NDA, UNCST, RECs).
Experience with supply chain management and/or logistics
Experience working in a clinical or medical laboratory environment
Experience with ISO or other regulatory clearance processes
Interest in medical device, technology, patient safety, clinical medicine or related fields
Strong problem-solving skills and ability to work independently.
Demonstrated ability to manage competing priorities in a fast-paced research setting.
Medical terminology and clinical exposure preferred

Salary Scale: Approximately 80,000,000-100,000,000 UGx. Necessary deductions in accordance with the current statutory laws of Uganda will be made at source. Dates: July 1, 2025 – June 30, 2026. With potential for extension depending on funding.
To submit an application, please send an e-mail to admin@anesthesiaug.org with your resume and cover letter with the subject title “Senior Clinical Research Coordinator Position.” Applications will be accepted until the position is filled.