Clinical Research Associate

Job Description

• Identify and qualify potential investigational sites.
• Coordinate and perform comprehensive site management.
• Conduct pre-study selection, site initiation, interim and close out monitoring visits
• Assist Project Manager/Clinical Trials Manager in completing and drafting study related plans
• Submit comprehensive visit reports and status reports in a timely manner
• Resolve and/or escalate logistical, data and audit issues
• Adhere to the study timelines and budget, in line with managers’ expectations
• Collect and review trial essential documents and prepare documents for ethics committee and/or regulatory submissions and supervise filing or assist in filing of essential documents
• Prepare materials for presentation at investigator meetings or site initiations and other project-related forums
• Ratio of travel and in-house activities (expected average): 70%:30%
• Handling inspections by regulatory agencies or (internal/external) audits.

Desired Candidate Profile

• Minimum 2 years of clinical research experience for CRA
• Life Science degree or equivalent or Registered Nurse
• Fluent in the English language and local languages as required for the performance of source data verification and communications; strong written and verbal communication in English
• Knowledge of ICH-GCP and applicable local and international regulatory guidelines (preferred)
• Demonstrated knowledge of clinical monitoring, follow company SOPs and applicable regulatory requirements
• Attention to detail and a methodical and systematic approach to work
• Strong interpersonal skills and an ability to communicate at all levels
• A proven ability to organize, take initiative and follow-up independently
• Knowledge of computer software: Microsoft Word, Excel, PowerPoint, Project, Visio, Outlook; SharePoint (preferred)
• Ability to travel up to 70% of time
• Candidate should have Minimum of a Bachelor of Science degree in a relevant scientific discipline.

Experience: 2 - 6 Years
Location : Bengaluru/Bangalore

Contact Details

Company Name : Adamas India Pharmaceuticals Pvt. Ltd.
Website : http://www.adamaspharma.com.
Executive Name : Bindhu John
Email Address : hr@adamaspharma.com