Clinical Trial Coordinator (Ctc)

• 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
• Track (e.g. essential documents) and report (e.g. Safety Reports)

• Obtain translations of documents
• Update manuals/documents (e.g., patient diaries, instructions)
• Prepare Investigator trial file binders
• Document proper destruction of clinical supplies.
• Execute eTMF Quality Control Plan
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Prepare documents and correspondence

• Publish study results for GCTO and RA where required per local legislation
• Support preparation of submission package for IRB/ERC and support regulatory
• Agencies submissions.
• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for:

• Calculate and execute payments (to investigators, vendors, grants)
• Track and report contract negotiations
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Develop, control, update and close-out country and site budgets (including Split site budget)
• Update and maintain contract templates (in cooperation with Legal Department)
• Monitor and track adherence and disclosures
• Maintain tracking tools
• Ensure adherence to financial and compliance procedures

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

• Highly effective time management, organizational and interpersonal skills, conflict management
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• 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.
• Proactive attitude to solving problems / proposing solutions
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
• Demonstrates commitment to Customer focus, both internally and externally.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• ICH-GCP Knowledge appropriate to role
• Minimum 1-2 yrs in Clinical Research or relevant healthcare experience
• ICON is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
• Able to work independently taking full ownership of delegated tasks
• Hands on knowledge of Good Documentation Practices
• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Excellent negotiation skills for CTCs in finance area
• Effective communication with external customers (e.g. sites and investigators)