Study Coordinator

Requirements

• Degree in Health-related tertiary qualification
• At least 3 years' experience in clinical research
• At least 3 years' experience as a Study Coordinator
• Knowledge of HIV /TB /STI's
• Knowledge of quality control, activities, systems and processes (QA/QC)
• Knowledge of ethical and regulatory compliance procedures and documentation required for clinical trials
• Knowledge of data quality assurance and quality control skills, including experience drafting standard operating procedures for clinical trials
• Study monitoring and evaluation skills, including regular report generation.
• Good work ethics
• Willingness to line manage counsellors if required
• Excellent communications skills (verbal and written)
• Planning and organizing skills
• Strong problem-solving skills
• Strong decision-making skills
• Attention to detail
• Ability to work independently and as part of a team
• Ability to work under pressure
• Valid Driver's License and own transport

Responsibilities:

Study management and implementation:

• The successful implementation and execution of studies and related protocols and SOPs to ensure smooth and successful running of studies from start up to archiving.
• Maintaining investigator site files (including Ethics communication, all versions of protocol and consent forms, staff details etc.) and documentation.
• Ensuring all staff have current CVs, GCP certification, and professional registrations
• Assisting with regulatory submissions
• Preparation of study documentation required for study visits and study operation (paper source documents, logs etc.)
• Responsible for staff training (including documentation) and oversight, data collection, and other administrative tasks.
• Ensure that QC/QA processes are followed
• Ensure that study specific lab and pharmacy documentation is complete
• Preparing for monitoring visits
• Ensure that the site is audit and inspection ready
• Work with the monitors to resolve queries timeously
• Ensure site and study SOPs are current and staff are trained.
• Ensure compliance with SOPs
• Monitoring recruitment and ensuring recruitment and retention targets are met timeously and maintained.
• Compiling of study progress reports for site and study meetings.
• Documentation of protocol deviations and implementation of CAPAs when necessary
• Ensure that all necessary equipment and consumables needed for conduct of the study are ordered, delivered and maintained.

Communication:

• Maintaining a positive relationship between site staff; between staff and participants and staff and any external stakeholders
• Maintain a positive relationship with monitors and sponsor project managers.
• Attend calls with study stakeholders.
• Since many studies require collaboration with international partners, after hours calls may be expected at a reasonable hour and at reasonable frequency.
• The site has a study phone so that participants are able to reach clinical staff 24/7. This is monitored on a rotational basis
• Clear communication of study successes and challenges with the PI and other site leadership

Site Related Activities:

• Participate in site meetings and take minutes when required.
• Adhere to all site operating procedures.
• Management of participant reimbursement as required.
• Working with line managers of other staff to ensure study and site cohesion.
• Promote the site and maintain the site's reputation with visitors, stakeholders and colleagues.
• Assist colleagues with communication with support services (e.g. IT, HR) to ensure smooth operation of the site

Line Management:

• Line-manage allocated staff (e.g. counsellors) and manage timesheets and leave forms
• Conduct performance assessments of relevant staff and provide constructive feedback to staff as per DTHF HR policies.
• Communicate with and assist HR department with regards to HR related pr