Become a Certified Monitoring & Evaluation Specialist
Clinical Trial Assistant
Purpose of the position
The Clinical Trial Assistant will offer the much-needed assistance to clinical trial teams including visceral leishmaniasis, mycetoma, and paediatric HIV in the course of the studies. S/he will mainly be concerned with management of the Trial Master File (TMF).
Specific job responsibilities
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of Trial Master file (TMF) for completeness.
- Assist clinical trial team in ethics and regulatory submissions.
- Assist clinical team with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Handle any other tasks as assigned
- Participate in efforts geared towards improving the effectiveness and efficiency of operations in accordance with the policies and procedures as laid down in the organization’s Quality Manual
Skills and attributes
- Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
- Very good communication skills in multicultural, multi-lingual environments
- Ability to work effectively as part of a multicultural team
- Well organized and structured
- Very good analytical skills
- Ability to contribute to the project delivery under minimum supervision
- Ability to manage small projects if delegated by upper levels with supervision
- Minimum of 3 years’ experience in clinical trials
- Proven ability to work effectively in a team environment and matrix structure
- Experience working with investigator site files/TMF/Regulatory submissions is desirable
- Diploma/Degree in health-related field.
- Knowledge of GCP/ICH
- Please submit your application using the online form
- Deadline for application: Accepting applications until 15 February 2019
- Only shortlisted candidates will be contacted