[Closing date: 13 August 2016]
Summary of Role
The Clinical Program Assistant will play a key role in the Clinical Team. S/he will act as a central point of communication for the extended Project Team. S/he will ensure general and transversal administrative and logistic project team support ensuring the smooth running of Clinical Trials. She/he will maintain and generate documentation pertaining to the management of the trial and will be a support in the management of Partners and Clinical Research Organization to ensure the above goals are obtained. As the Clinical Program Assistant s/he will be expected to maintain frequent interaction with the DNDi Project team and to follow up the DNDi budget for his/her given studies.
S/he will work with the Regional Offices operational teams, some international travel is expected.
S/he will report to the Head of Diseases Programs and Clinical Project Manager.
- Coordinating planning and reporting of clinical projects and study team activities
Work with other team members to gather information to keep project schedules up-to-date and flag upcoming activities and milestones to the project team
- Coordinating administrative aspects in the execution and management of clinical trials
- Support office administration: Coordination of travels (in liaison with travel assistant), coordination of internal and external meetings, writing of correspondence, teleconference and meeting minutes with support of the relevant teams, preparation of presentations, tables and statistics as required etc.
- Ensuring maintenance of the filing team work documents in the requested filing software
- Support in follow up of budget and invoices
- Support Geneva and Kinshasa team in logistic organizations ( preparation of records, documentation, etc.
All tasks must be conducted in accordance with applicable DNDi Policies, Guidelines, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations.
- To provide General administrative project team support:
- Acting as a central point of transversal communication for the extended Study Team in defining supply logistics, sending out team updates, organizing team meetings, keeping and distributing minutes, regular calls with staff across the extended team to gather updates, issues and progress etc.
- Acting as central point for all travel support especially visit to field of the staff member and external visitors in liaise with regional office
- Maintain and updated travel record and planning
- Assist in or organize the translation of English texts into local language(s) (if applicable)
- Provide progress reports to the Head of Disease Program and for internal use on individual projects including budget updates on a regular basis.
- Coordinate monthly progress report
- Support Clinical Team in
- Study Submission work and amendments
- SAC meeting preparations
- DSMB meetings organizations and preparations
- Training meetings related to the studies
- To participate in Study-related activities:
- Participate in the creation/design of study aides and Liaise with external party/vendor /copy shop to produce trial related aides e.g. diaries, questionnaires, emergency cards, and other study related forms, as requested.
- Arrange for translations and quality control in different languages, as required. Ensure adequate stocks are available and necessary documents are provided to the sites/Monitors in a timely manner, as required.
- Assist the Geneva and Regional office teams in the development of clinical trial tools
- Coordination in the editing and distribution of trials news letter
- Organize project meetings as required (e.g. Team meetings, Trial monitor meetings, Drug Safety Monitor Board meetings, DNDi CTM meetings, Trial Team meetings (logistics with regional offices), Investigator meetings, teleconferences,
- Responsible for documenting meeting minutes and actions and for the timely review and distribution of minutes and actions to allow management of actions and activities between meetings
- Assist in the development of presentations as required
TRIAL SITE LOGISTIC SUPPORT
In liaison with the ROs teams (logistic Officer, Regional Operations Manager, Finance and Administrative Officers)
- Follow-up and update budget information and provide logistic support as necessary. Track invoices and maintain tracker
- Support in contract writing and follow-up of the contract execution
- Follow- up and update monitoring planning and site visit information
- Participate in monitoring teleconference and other teleconferences as required
- Degree in relevant field
- Experience in clinical research, especially in phase II/II studies multicentre studies, different region of countries as well as in various study stages (i.e. start-up, conduct, close-out and experience in all these aspects of running a study)
- Good knowledge of the applicable regulations for clinical trials and of ICH-GCP
- Understanding of records management best practices
- Ability to manage projects and to conduct meetings
- Fluent in English
- Good practice with usual software (Word, Excel, Power point, MS Project would be a plus)
The Clinical Program Assistant reports to the Head of Disease Program and is in liaison with the Clinical Project Managers and project teams
- For additional information about DNDi please visit our website at www.dndi.org
- Accepting applications until August 13th 2016.
- Only shortlisted candidates will be contacted