Assists with technical and administrative support for projects in collaboration with internal departments and project team members.
Attends amendment strategy meeting, as applicable and required.
Develops templates (e.g., Essential Documents Checklist, welcome email) at a study level following instruction from a project team.
Ensures that trial status information relating to site activation activities and amendments is tracked in applicable systems and accurately maintained in database(s) at all times.
Supports updates to the Essential Documents Checklist based on each amendment.
Supports eTMF compliance (study, country, and site levels) by identifying/highlighting gaps and following up with project team members.
Supports start up and amendments conference calls; documents, completes, and distributes meeting minutes from internal/client meetings, as applicable.
Requests resources in Clarity and follows up on assignments.
Tracks amended documents in CTMS.
Reviews timesheet reports related to amendments task code and follows up with individuals who have overburn hours related to amendments to determine the rationale and requests additional hours.
May assist with audit and inspection preparation.
May support preparation and distribution of the Amendment Progress Report and other applicable study reports to project teams to act on compliance gaps as applicable, directly in systems, providing a deadline for feedback.
Education & Experience
High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job.
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 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 Strong customer focus.
Good time management skills, including 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/work instructions for all non-clinical/clinical aspects of project implementation, execution and closeout.
Good English language and grammar skills and proficient local language skills.
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.
