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Medical Officer/Study Coordinator (PACMan Study)
Job Summary
The Medical Officer/Study Coordinator at UNC Project will act as the central catalyst for all PACMan study activities. Key responsibilities include: coordination of project staff; overseeing the study team for day-to-day project activities; communicating closely with the PACMan PI, PRISM Overall PI/ CSO, and co-investigators; being the main liaison for all project stakeholders, including colleagues from MOH and PEPFAR implementing partners; following the project work plan; and encouraging the study team to follow the study protocol, SOPs, tools, and UNCPM procedures. In addition, the Medical Officer/ Study Coordinator will work with the study team to develop and implement all study policies, procedures, and tools, as well as support training, guidance, and mentoring to study staff working on the PACMan study. S/he will collaborate with other disciplines and healthcare staff to ensure optimum care for study participants. S/he will participate in quality improvement activities. S/he will be responsible for tracking and reporting all adverse events.
Specific Duties/Responsibilities
- Develop SOPS, checklists, study forms, and registers to improve quality of study implementation.
- Support creation, monitor translation and assist maintaining version control of study Informed Consent Forms, including translated versions, and other required study documents.
- Co-develop work plan in conjunction with stakeholders
- Support the recruitment of appropriate staff in collaboration with the PACMan PI
- Assess staff training/mentoring/coaching needs and assist with development and provision of training/mentorship to study staff to update/maintain competence of study staff.
- Assist in organizing all aspects of study staff training to enable study personnel to fulfill study/program responsibilities.
- Coordinate all aspects of quantitative and qualitative data collection, quality control, reporting and storage.
- Support project progress reports and presentations to funder (NIH) and other stakeholders as required, including for internal M&E and quality assurance purposes.
- Oversee management of study regulatory documents.
- Maintain Human Subjects Protection (HSP) and Good Clinical Practices (GCP) principles and certification, as well as confidentiality at all times.
Research
- Be knowledgeable of and adhere to the study protocol.
- Develop and maintain study M&E and quality assurance systems, in collaboration with Data Manager and Data Associate, to ensure optimum study function and quality research data.
- Assess, manage, and report adverse events and serious adverse events.
- Implement research protocols and/or Standard Operating Procedures (SOPs)
- Work effectively with UNC Project partners to ensure excellent intervention delivery at study sites
- Collect timely comprehensive, legible, accurate and complete clinical data from eligible study participants, assuring good data quality
- Support delivery of PACMan intervention with competency and according to study protocols/SOPs
- Preparing and maintaining essential and regulatory study documents.
- Assist with planning, writing, editing and submission of abstracts/manuscripts and other knowledge dissemination activities.
Communication and Working Relationships
- Maintain an effective means of communication with different study departments, work colleagues, other health workers, study participants and visitors.
- Participate in local and international clinical/multi-professional meetings and conferences as required
- Promote and safeguard the interest and well-being of the study participants at all times
Personal and People Development
- Develops and maintains continuing personal and professional development to meet the changing demands in the area of research.
- Act as a role model in professional and personal attributes for all members of staff
- Participate in the orientation of new staff and act as a preceptor and mentor
- Contribute to Continuing Professional Development (CPD) of staff
Management
- Oversee preparation and submission of field allowances, receipts and reconciliation registers as required.
- Support the monthly review and monitoring of project expenses with project manager and MPIs as well as budget reviews as necessary and solicit appropriate approvals.
- In conjunction with administration, maintain appropriate inventory tracking mechanisms.
- Supervise study staff
- Ensure efficient management of study resources
- Participate in the maintenance of accurate and up-to-date records in accordance with the Medical Council of Malawi
Health and Safety Responsibilities
- Comply with existing health and safety policies and procedures of the UNC Project and Malawi Ministry of Health (MOH).
Quality Assurance
- Adhere to the study protocol quality assurance, quality control policy, guidelines, and procedures.
Further Information
The post holder must at all times:
- Work in accordance with the Medical Council of Malawi Code of Professional Conduct and Disciplinary Procedures
- Strictly adhere to the provisions of the Patient’s Charter as provided by the MOH.
- Participate in National Health Programs
Qualifications and Experience
- MBBS, MB.Ch.B, or equivalent
- Permanent Certification / Registration with the Medical Council of Malawi
- Continuous Professional Development (CPD) track record
- Must have completed 2 years internship in an accredited Health institution
- Must have at least 2 years of research experience in a study coordinator or study medical officer role
- Must have an active human subjects protection certificate
Knowledge
- Knowledge of MOH Patients’ Charter
- Knowledge of Health and Safety measures
- Knowledge and understanding of quality assurance issues
- General Knowledge of health-related issues
- Knowledge of HIV
- Knowledge of research methods
Advanced life Abilities
- Basic life support/resuscitation skills
- Excellent interpersonal skills
Please send your applications via email to:
The Country Director
UNC Project
Lilongwe
Email:
administration@unclilongwe.org
Deadline for receiving applications: Wednesday, May 22, 2024
Only shortlisted candidates will be acknowledged.
