Study Coordinator (UNITAID PSI Study)

A study coordinator plays a pivotal role in the execution and management of clinical trials conducted at the research site. The position needs to acquire in-depth knowledge of relevant study protocols and will be responsible for coordinating various aspects of the clinical trial process to ensure compliance with regulatory standards, protocol requirements, and quality standards across the major aspects of clinical research including study management, data collection, participant care, participant advocacy and recruitment. This role demands meticulous attention to detail, excellent organizational skills, and effective communication abilities to facilitate seamless collaboration among research team members, sponsors, and participants. Specific duties and requirements may vary depending on the study protocol and site structure.

·Overseeing quality control for the specific study to ensure data integrity, protocol compliance and completion.

·Ensuring strict adherence to study protocols, regulatory guidelines, ethical and good clinical practice guidelines as well as TASK standard operating procedures (SOPs) whilst ensuring participant safety throughout the conduct of the clinical trial.

·Assisting (Assistant) Site Manager in preparing for study setup/start.

·Coordinating, tracking and performing clinical activities, including scheduling study preparation, set-up and readiness, participant visits, performing study procedures according to scope, relevant compliancy checks, quality and timely data collection and entry.

·Performing the preparation, maintenance, quality checks and completion of study documentation, including source and study logs.

·Maintaining accurate study documentation according to good clinical practice (GCP) and ensuring compliance with regulatory requirements and ethical guidelines.

·Performing electronic data capturing and validation.

·Preparing, coordinating, and facilitating audits and inspections.

·Maintaining an adequate supply of study laboratory kits and consumables and supporting sample processing staff in various functions such as processing and shipping samples, while ensuring good documentation practices.

·Educating participants on study related requirements and compliance.

·Familiarising themselves with study protocol and medical tools and procedures.

·Maintaining accurate and complete records of protocol deviations and share regularly with Principal Investigator and Assistant Site Manager.

·Screening of potential participants according protocol guidelines and eligibility criteria.

·Maintaining accurate participant records and ensuring informed consent procedures are followed.

·Assess the HIV prevention care and support needs of each client and prepare a plan together with the program manager.

·Provide outreach clinical services i.e., phlebotomy, and screening for HTS, STI and TB, HBV and HCV,

·Ensure that all medical services provided during outreach need to adhere to National Department of Health guidelines and policies, and ensure that we reach and surpass the targets.

Project Support               and Administration

·Providing statistics on portfolios delegated.

·Assisting with setting of goals, objectives, and interventions for quality service delivery.

·Ensuring all medical equipment is in working order, and that we have all the clinical supplies and stationery we need in the project.

·Adhering to Health and Safety and Infection Control Policies and Procedures.

·Implementing and maintaining quality assurance programmes: Ideal Clinic Realisation and Maintenance (ICRM) and National Core Standards (NCS) with support and guidance from Anova

·Assisting with Assessments.

·Implementing Rapid Test Continuous Quality Improvement: Independent Quality Control and Proficiency Testing for HIV RDTs.

·Attend meetings, briefings, debriefing, staff meetings and other as directed to do so on a regular basis.

·Responsible for driving yourself and your team to the sites of work as and when required, and you should adhere to the Anova vehicle management policy

·Additional responsibilities delegated by managers from time to time.

Qualifications and Experience

·Relevant bachelor’s degree

·Good Clinical Practice Course Certificate

·At least 2 years’ experience in project or operations management

·At least 2 years’ experience in HIV or public health environment

·Able to demonstrate ability to update and maintain a data register.

·Computer Literate – MS Office Packages (MS Outlook, MS Word, MS Excel & PowerPoint).

·Excellent Communication skills and ability to speak one of the local languages

·Ability to travel as and when required

·Innovative, organized, analytical and excellent interpretation data skills