- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager, as appropriate.
- Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
- Provides system support and document tracking (i.e. Activate & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials, including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Trains new personnel in processes and systems.
- May attend Kick off meeting and take notes when required.
- May support start-up team to work with sites to collect required essential documents, in preparation for ethics or regulatory submission, including uploading of documents into relevant systems and portals.
- May support scheduling of client and/or internal meetings with completion of related meeting minutes.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Keys to Success
Education and Experience:
- Bachelor's degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to < 1 year).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with ability to handle multiple tasks efficiently and effectively
- Ability to analyze project-specific data/systems to ensure accuracy and efficiency
- Flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
- Ability to attain and maintain a good understanding of applicable Country Regulations, ICH and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout
- Good oral and written English language communication skills and proficient local language skills as needed
- Strong IT skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to complete CRG clinical training program
