PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Clinical Research Associate I CPS
Job Description:
Build relationships with investigators and site staff
• Participate in Investigator and other external or internal meetings as required
• Arrange on-site visits and logistics (e.g. travel arrangements)
• Perform on site visits in accordance with the monitoring plan
• Conduct on-site study-specific training (if applicable)
• Perform site facilities inspection
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
• Monitor and maintain compliance with ICH-GCP Guidelines, local regulatory requirements, PAREXEL and/or Client SOPs, and study specific procedures
• Responsible for the completeness and quality of the on-site files
• Respond to site issue alerted by the project team (i.e., non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
• Collect SRP documents during QV and other visits as needed
• Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
• Update all relevant tracking system on an ongoing basis
• Generate visit/contact report in accordance with monitoring plan
• Code and scan Central File documents where applicable
• Ship relevant wet-ink signature documents to the Assistant or back to the site
• Escalate any issues that require immediate action to the Coordinator or COL
• Inform responsible CRA Coordinator/COL/Manager of work status regularly
• Attend audits / Regulatory Inspection if requested
• Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel
• expense claims)
• Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor
Skills
• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
• Strong regulatory knowledge including GCP
• Excellent interpersonal, verbal and written communication skills
• Sound problem solving skills
• Ability to successfully work in a (‘virtual’) team environment
• Sound presentation skills
• Consultative skills
• Client focused approach to work with the ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Able to take initiative and work independently
• Sense of urgency in completing assigned tasks
• Able to travel a minimum of 65% on average
• Holds a driving license where required
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work
Education
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience.
Language Skills
• Competent in written and oral English.
Minimum Work Experience
• Previous work experience (e.g. CR Assistant, nursing, laboratory, data management) would be advisable.
Additional Information:
Location: Mumbai
Functional Area: CR
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
pare: 10043388
End Date: 30th May, 2015
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