Découvrez une carrière au service d’une plus grande cause

ASSIGNMENT PROFILE
Clinical Trial Coordinator (CTC)
Description of Roles and Responsibilities
• Trial and site administration:
o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request
Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents
o Assist with eTMF reconciliation
o Updating manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Execute eTMF Quality Control Plan
o Obtain translations of documents
• Regulatory & Site Start-Up responsibilities:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Develop country and site budgets (including Split site budget)
o Tracking, and reporting of negotiations
o Maintenance of tracking tools
o Contract development, negotiation, approval and maintenance (e.g. CTRAs)
o Update and maintain contract templates (in cooperation with Legal Department)
o Payment calculation and execution (investigators, vendors, grants)
o Ensure compliance with financial procedures
o Monitor and track adherence and disclosures,
o Budget closeout.
• Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols)
o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Experience Required
Minimum 1-2 years in Clinical Research or relevant healthcare experience
Note - Specific experience requirements may vary depending on the Country
CRA R CTC Role Profile 07-Jun-2017

Educational Requirements
B.A./B.S. (Life Science preferred) or equivalent healthcare experience
CORE Competency Expectations
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• 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
Behavioural Competency Expectations
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency. 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.
• Able to work independently
• Proactive attitude to solving problems / proposing solutions

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com