Job Description
- Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn).
- Supports the maintenance of study specific documentation and systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
- Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents and maintaining audit readiness.
- Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews and coordinating for issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes.
- Exports and prepare study metrics reports.
- Maintain vendor trackers.
- Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager.
- When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.
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Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Knowledge, Skills and Abilities:
• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Good time management skills. Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country
Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Good English language and grammar skills and proficient local language skills (if required). Effective oral and written communication skills
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems
• Ability to successfully complete CRG training program
• Self-motivated, positive attitude and good interpersonal skills