- Regulatory Clinical Trial Coordi...
This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTA Manager, the person prepares, collates, distributes and archives clinical documents.
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to Support CTRAs payments tracking.
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
- Clinical supply & non-clinical supply management, in collaboration with other ｃｏｕｎｔry roles
- Manage Labeling requirements and coordinate/sign translation change request
· Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- ｅｘｅｃute eTMF Quality Control Plan
- ｕｐｄａｔｅ manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
· Regulatory & Site Start-Up responsibilities:
Collaborate with other ｃｏｕｎｔry roles to:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
· Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
- Monitor and track adherence and disclosures
- Maintain tracking tools
- Organize meetings (ｃｒｅａｔｅ & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, ｓｅｌｅｃｔ venue, support vendor where applicable)
CORE Competency Expectations:
· Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
· Hands on knowledge of Good Documentation Practices
· Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
· ICH-GCP Knowledge appropriate to role
· Excellent negotiation skills for CTCs in finance area
Behavioural Competency Expectations:
· Effective time management, organizational and interpersonal skills, conflict management
· Effective communication skill
· High sense of acｃｏｕｎｔability and collaboration. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
· Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
· Demonstrates commitment to Customer focus, both internally and externally.
· Able to work independently after internship
· Proactive attitude to solving problems / proposing solutions
· Positive mindset, growth mindset, capable of working independently with assigned tasks
· Completed job training (office management, administration, finance, health care, supply chain preferred) or B.A./B.S. (Life Science/Pharmacy/Supply Chain preferred) or equivalent healthcare experience.
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