Job Summary:
Performs research development with senior research staff to develop, implement, manage, and conduct research studies. Makes detailed evaluations, observations, analyzes data and interprets results using qualitative/quantitative methods and statistics. Investigates, creates and develops new methods and technologies for project advancement.
LINKAGES Clinical Study Manager will oversee the PrEP research study under the LINKAGES Swaziland program. Through guidance provided by the MOH’s Swaziland National AIDS Programme (SNAP) and supported by PEPFAR/Swaziland, FHI 360 LINKAGES Swaziland will implement a number of research activities including, but not limited to, looking at 1) access to pre-exposure prophylaxis (PrEP) as one of the HIV Prevention Services provided in its current service delivery model and 2) HIV self-testing (HIV ST) (optional)
Accountabilities:
- Manages the day-to-day operations LINKAGES study sites including start-up, conduct, and close-out activities.
- Work closely with assigned team to ensure activities are implemented per standard operating procedures (SOPs).
- Lead problem solving and resolution efforts to include management of risk, contingencies and issue resolution.
- Work with data manager to develop data flow chart to guide data collection, storage, transportation, cleaning and analysis.
- Possesses knowledge of and remains compliant with local, international and USG requirements and other related regulations regarding confidentiality and ethical issues of research subject data.
- Conduct site visits, when necessary, this includes: convene meetings with study team, prepare and/or edit meeting minutes and process briefings to ensure study continuous quality improvement.
- Creates and manages overall operation of the entire study including project planning, budget, and resource management.
- Ensures strong client relationship management through clear communications, decisive escalation of issues and coordination with other project leadership.
- Ensures that study timelines, costs, and quality metrics are established and met.
- Prepares research concepts and proposals following established policies and procedures.
- Conducts data analysis, data reviews, and reporting of research data for evaluation and quality.
- Assists with the design and implementation of research studies, including the sampling, recruitment, and statistical analysis
- Ensures compliance with government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts.
- Develops training materials and conducts training for study implementation based on company policies and standard operating procedures (SOPs).
- Provides input with questionnaire development, analysis, study design, and material management.
- Plans, organizes, and manages resources/processes for successful completion of study goals.
- Develops and implements protocols and informed consents for research studies. Provides guidance on any protocol related issues.
- Manages and oversees budget for one or more research projects.
- Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.
- May act as team lead and mentors staff on training, systems, policies, and regulations.
- Serves as the liaison with internal and external partners to ensure effective collaboration efforts.
- Oversees planning of meetings, site visits, and drafting necessary documents.
Education:
- Master’s Degree or its International Equivalent • Knowledge/Information Services, Communications, Education, Environment, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
Experience:
- Typically requires 5-8 years of research or evaluation experience with manuscripts, and study implementation.
- Proficiency in Microsoft Office. spreadsheets, analytical software and other technology required.
- Experience in clinical research protocol review, study ethical consideration and implementation of HIV clinical care.
- Experience in mentoring of health care workers on research studies conduct
- Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
- Must be able to read, write and speak fluent English.
- Related prior work experience preferred.
Travel Requirements:
- 10%-25%
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
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FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
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