Job Description
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration. The role will collaborate at local level closely with CRA and CTC. Responsibilities include, but are not limited to
- Trial and site administration
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Document management
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Prepare Investigator trial file binder
- Meeting Planning
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
- Support Local initiatives
- Create posters and videos
- Improvement in local process using technologies such as automation, coding, AI
With oversight of Sr.CRA/CRA and/or CRA-Manager, support site management as appropriate including but not limited to
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Assist site visits as appropriate including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
COMPETENCY EXPECTATIONS
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Knowledge of Good Documentation Practices.
- Understanding and developing skills in Site Management including management of site performance and patient recruitment.
- Developing level of monitoring skill and independent professional judgment.
- Good IT skills such as automation, video editing, coding, AI.
BEHAVIORAL EXPECTATIONS
- Effective time management, organizational and interpersonal skills, conflict management
- Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
Required Skills
- Competency Management
- Competency Management
- Conflict Management
- Cultural Awareness
- Customer Centricity
- Customer-Focused
- Database Management
- Data Documentation
- Data Entry
- Decision Making
- Document Management
- Email Management
- Event Planning
- File Management
- Inventory Management
- Line Management
- Matrix Management
- Meeting Facilitation
- Meeting Management
- Meeting Organization
- Minute Taking
- Multitasking
- Office Management
- On Site Management
- Payment Handling {+ 8 more}
Employee Status
Intern/Co-op (Fixed Term)
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
- A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID
R412179