Clinical Research Associate

1 day ago

New Delhi, India Zillan Clinical Research Full time

Clinical Research Associate assistant / Senior Clinical Research Coordinator

Seeking highly motivated Clinical Research Associate/ Senior Clinical Research Coordinator to work remotely

This role will be a part time or full-time position during standard business hours in USA

Job Overview
Responsibilities for Clinical Research Associate/ Senior Clinical Research Coordinator includes:

- Performs site qualification, site initiation, interim monitoring, site management and closeout visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs
- Assesses site processes
- SDR and SDV
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Perform investigational product (IP) inventory, reconciliation and reviews storage and security
- Process and track SAEs
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

JOB REQUIREMENTS

Knowledge/Skills/Education/Licenses:

- Bachelor's degree
- Minimum of 1 year as a monitor or 2 years as a CRC
- Knowledge of clinical research industry, terminology and practices.
- Background as a clinical research coordinator is preferred
- **Excellent written and verbal communication skills**
- Superior organizational and time management skills
- Capable of working independently with mínimal supervision and also as part of a team
- Skilled with standard computer programs including the MS Office suite
- Understanding of research terminology as well as standard clinical procedures and protocol
- Qualified applicants should forward their CVs

COVID-19 considerations:
All applicants must be vaccinated and will wear a mask

**Job Types**: Full-time, Part-time, Contractual / Temporary
Contract length: 12 months
Part-time hours: 40 per week

**Benefits**:

- Flexible schedule

Schedule:

- Day shift
- Flexible shift
- Monday to Friday
- Rotational shift

**Education**:

- Bachelor's (required)

**Experience**:

- Microsoft Office: 1 year (required)
- Clinical research: 1 year (required)
- Time management: 1 year (preferred)

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