Overview
Clinical Trial Coordinator Supplies/Término Fijo Jobs in Rahway, New Jersey, USA at MSD Malaysia
Position: Clinical Trial Coordinator Supplies (Término Fijo)
time left to apply End Date:
April 21, 2025 (25 days left to apply)
job requisition R341445
Job Description
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC (Clinical Trial Coordinator) 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 manage CTRAs and payments.
Responsibilities include, but are not limited to:
Trial and site administration:
Ensure collation and distribution of study tools and documents
Clinical supply & non-clinical supply management, in collaboration with other country roles
Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
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
Document proper destruction of clinical supplies.
Prepare Investigator trial file binders
Meeting Planning:
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Skills:
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
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, both internally and externally.
Able to work independently
Proactive attitude to solving problems / proposing solutions
Positive mindset, growth mindset
Qualification &
Experience:
Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree
Employee Status:
Project Temps (Fixed Term)
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Title: Clinical Trial Coordinator Supplies/Término Fijo
Company: MSD Malaysia
Location: Rahway, New Jersey, USA
Category: Healthcare (Healthcare Administration), Administrative/Clerical (Healthcare Administration)
