Clinical Researh Coordinator

2 weeks ago

Petaling Jaya, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full time

**Responsibilities**:

- Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority
- Communicate with sites, Lilly functions, clinical research organization to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Compose initial Informed Consent Form or amendments based on country ICF template as well as response to queries by Ethic Committees
- Coordinate the management and delivery of clinical trial material to ensure support of site initiation
- Populate internal clinical trial systems (e.g., Vault Clinical, Shared Investigator Platform, IMPACT) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
- Ensure complete, accurate and readily available Trial Master File

**Minimum Qualification Requirements**
- At least Bachelor’s degree preferably in a scientific or health related field, postgraduate degree is also welcomed
- 1-4 years clinical research experience or relevant experience preferred Understanding of the overall clinical development paradigm and the importance of efficient site activation
- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
- Effective communication, negotiation, and problem-solving skills
- Self-management, able to multitask and good organizational skills
- Language capabilities - English (read, write, conversation)

**Job Types**: Full-time, Permanent

**Salary**: RM5,200.00 - RM6,500.00 per month

**Benefits**:

- Cell phone reimbursement
- Dental insurance
- Health insurance
- Maternity leave
- Opportunities for promotion
- Professional development

Schedule:

- Day shift
- Monday to Friday

Supplemental pay types:

- Yearly bonus

Application Question(s):

- Have you worked with clinical trial start up activities ?
- Have you coordinated the delivery of clinical trial material to site?
- What is your notice period like?

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