Sr. Amendment Implementation Coordinator

Essential Functions

• Supports amendment activities.

• 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.