Clinical Research Associate (CRA)
บริษัท สกิลพาวเวอร์ เซอร์วิส (ประเทศไทย) จำกัด- Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.
- Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensure safety and protection of study subjects per the monitoring plan, SOPs, ICH Guidelines, and federal regulations.
- Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
- Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator), peers and office-based personnel.
- Identify, evaluate and recommend new/potential investigators/sites on an on-going basis.
- Participate in AN departmental and clinical study team meetings.
- Employ good fiscal management to conserve costs of departmental operation and control travel expenses, with guidance from the Clinical Operations Project Lead and managers.
- Appropriately escalate serious or outstanding issues to the Clinical Operations Project Lead or the appropriate project team member(s).
- Facilitate Quality Assurance Audit processes as indicated.
- Ensure regulatory inspection readiness at assigned clinical sites.
- Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.
- Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
- Travel up to 30% for onsite monitoring
- Bachelor’s Degree, preferably in Pharmacy, clinical science/nutrition/nursing field or Associate's Degree/RN with relevant clinical experience is required
- Minimum of 2 years of clinically-related experience especially in clinical research monitoring
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
- Solid knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations
- Experience in on-site monitoring of investigational products (e.g. drug, device, medical food, and/or infant formula) is required.
- Demonstrated strong site management and monitoring skills
- Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Good written and verbal communication skills
- Good Command of English
- Acute observational skills, analytical and conceptual capabilities
- Exhibit high degree of flexibility when facing changes in the work environment
- Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
- Previous experience with electronic data capture systems desirable
- Strong ability to work independently with minimal supervision.
Location: South Sathorn Rd., Bangkok (MRT Lumpini)
This is a contract position with Manpower for 1 year (renewable or able to convert to permanent base on company consideration) with benefits (Fix and Variable Bonus, Travel Allowance, etc.)
- Annual leave
- Life and Health Insurance
- Medical insurance
- Travel allowance
- กองทุนสำรองเลี้ยงชีพ
- ค่าใช้จ่ายในการเดินทาง
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- โบนัสตามผลงาน/ผลประกอบการ
- โบนัสประจำปี
Manpower Inc. is a world leader In the employment services Industry, offering customers a continuum of services to meet their needs throughout the employment and business cycle. The company specializes in permanent, temporary and contract recruitment; employee assessment; training; career transition and organizational consulting services. Manpower’s worldwide network of 4,500 offices in 80 countries and territories enables the company to meet the needs of its 400,000 customers per year, including small and medium size enterprises in all industry sectors, as well as the world”s largest multinational corporations. The focus of Manpower”s work is on raising productivity through Improved quality, efficiency and cost-reduction, enabling customers to concentrate on their core business activities. In addition to the Manpower brand, the company operates under the brand names of Right Management Consultants, Jefferson Wells, Elan, Brook Street and Empower.
Manpower Thailand is the nation’s leading recruitment company established in 1998 to offer human resources management services to businesses in search of staff and people in search of job. The company currently has 10 offices in Thailand cover in Bangkok, Chonburi, Lamphun and Songkla to cover the needs of corporate clients and job seekers.