Study Coordinator

7 months ago

Durban, South Africa THINK Full time

THINK is a non-profit organization dedicated to improving the lives of those vulnerable populations worldwide. As a health delivery and research organisation, THINK engages with the local community, government consortia, and international funders to provide care and carry out cutting-edge clinical research that has already contributed to changing treatment guidelines internationally and locally.

THINK is looking for a qualified Study Coordinator to ensure that the studies allocated to the Site (Clinical Trial Unit) deliver to Organisational standards and Sponsor (Funder) expectations through providing leadership to the Site team. As Study Coordinator, to be responsible for operational aspects for the implementation of clinical trial activities ensuring Good Clinical Practices (GCP's) and relevant Standard Operating Procedures (SOP's) are met.

**Duties and Responsibilities include but are not limited to**:

- Ensure sufficient resources for the trial unit staff to conduct their duties and fulfil the obligations to funders.
- Responsible for CTU compliance with clinical research and ethics regulatory practice.
- Quality control management and periodic inspection of work carried out.
- Designing and implementing Standard Operating Procedures for the trial.
- Preparation of site and project before and after site activity takes place.
- Collaborate with the Finance Officer allocated to the unit for accountability of all expenditure and best use of funders’ resources at site.
- Daily operation of the unit including co-ordination of meetings, trainings and communication with funders.
- Work together with the operations team to ensure facilities and equipment maintained.
- Contribute towards the successful delivery of clinical trial and research projects that aim to enhance THINK’s vision and mandate.
- Actively participate and contribute towards the successful completion of large-scale projects as part of the trial unit team.
- Contribute towards the delivery of high-quality reports within agreed deadlines and timescales.
- If the opportunity arises, to assist in the preparation of professional research proposals to secure research projects.
- Prepare progress reports on the status of ongoing research studies and share timeously with relevant stakeholders, internally and externally.
- Proactively raise any threats to the successful completion of the projects within the unit and take corrective measures where necessary.
- Contribute towards continuously ensuring that all research practices and processes are geared towards the cutting-edge delivery of research that contributes towards the public good.
- Ensure proper alignment of all research studies with the objectives of the organisation.
- Contribute towards the creation of a Research Centre of Excellence that provides cutting-edge research solutions.
- Contribute towards the creation of research quality standards that align to the strategic objectives of the organisation.
- Continuously strive to exceed all quality standards in all research studies undertaken.
- Embark on continuous development initiatives aimed at automating research practices and employing cutting edge technologies.
- Contribute to the betterment of THINK, e.g. grant writing, protocol development, contribute to publications/study reports.
- Convene and attend meetings and present relevant information to stakeholders when required.
- Ensure the provision of excellent customer service.
- Resolve queries and problems within span of control and within agreed time frames.
- Follow up on unresolved queries and complaints where required.
- Liaise with relevant stakeholders regarding follow-up of information, as required.
- Manage internal and external relationships to ensure that research best practices are implemented across the organisation.
- Ensure strict adherence to all research requirements.
- Maintain ethical and GCP principles throughout research conduct.
- Assist in identifying and adhering to fraud controls, risk prevention principles, sound governance and compliance processes, and tools to identify and manage risks for the organisation.
- Support and provide evidence to all internal and external audit and regulatory requirements where necessary.
- Maintain quality risk management standards in line with regulatory requirements.
- Maintain and enforce all related Service Level Agreements to minimise business risk and ensure business continuity.
- Adhere to all relevant laws, policies and Standard Operating Procedures throughout the organisation.

**Requirements**:

- A completed Diploma or Degree in the filed of Health or Project Management.
- Knowledge of active medical research with 3 years or more in project preparation.
- Experienced in research mythology.
- Direct TB and HIV related research is advantageous.
- Excellent communication skills, both verbal and written.
- Ability to work collaboratively and cross-functionally with teams and external partners.
- Demonstrated ability t

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