Job description
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
Job requirements
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
Experience
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
Education
Diploma/Degree in health-related field.
Knowledge of GCP/ICH
