Clinical Trials Research Associate
2 days ago
**SUMMARY**
A part of the Study Support team the Resaerch Associte is responsible for performing work in the following operational areas as directed. The items below are a list of all planned duties of this role. The implementation of these duties will be staged as appropriate.
**STATUS**:Full time
**LOCATION**: Mumbai - Hybrid
**DEPARTMENT**: Study Support
**SCHEDULE**:Monday to Friday, days
**ATTRIBUTES**:
- Minimum Graduate degree required. Preferred Master’s degree in the fields of Bio-chemistry, Microbiology, Chemistry, Bio-technology or scientific concentration required.
- Preferred 1 year direct health care experience, central laboratory experience.
- Excellent verbal and written communication skills required.
- Computer proficiency required; familiarity with relational databases and reporting tool strongly preferred.
- Ability to multi-task and prioritize workload required.
- Customer Service experience required.
- Critical thinking and ability to problem-solve.
**RESPONSIBILITIES**:
- **Data Management**. Use of CTMS functionality for recording data cleaning-related action item (AI) comments. All aspects of data (to include action items/CTAs) cleaning including site contact, escalation to ACM Project Manager (PM) according to the appropriate Standard Operating Procedure (SOP), resolution and sample release from the CTMS system, and filing of associated documentation. Tracking of reference laboratory results and entry into CTMS according to the agreed time frames. Ensure that appropriate laboratory staff are informed of received reference laboratory results, so that they can authorize the results in a timely manner. Filing of reference laboratory results.
- **Quality & Regulatory**: Participates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies. Performs duties with a general working knowledge of Regional Regulatory bodies, GCP, GDP, ICH and other pertinent regulations, as pertains to central laboratory function. Actively assist the department director/head and reporting manager in the smooth functioning of the office. Understands and follows company policies and procedures while always maintaining confidentiality, both inside and outside of the work place. Maintain financial performance of company by executing on job duties as specified and by proactively and continuously bringing to management’s attention ideas to improve productivity, service, quality, cost savings, process improvements, policies & procedures, and utilization of company resources. Improve job knowledge by in-house, outside work, self-study, and on-line training in addition to industry functions, certifications, publications, and other available training resources
Pay: ₹300,000.00 - ₹350,000.00 per year
**Benefits**:
- Life insurance
Schedule:
- Monday to Friday
- Weekend availability
Ability to commute/relocate:
- Andheri, Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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