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 II
Job Description
• Build relationships with investigators and site staff.
• Act as PAREXEL’s direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
• 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; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training.
• Conduct remote visits as requested/needed.
• Conduct on-site study-specific training (if applicable).
• Perform site facilities inspection.
• Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead (FL).
• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
• Ensure that assigned sites are inspection-ready
• Monitor and maintain ICH-GCP compliance
• Monitor and maintain completeness and quality of the on-site files
• Respond to site issues as alerted to and identified by the Clinical Monitoring Associate (CMA) (i.e. non-responsive site, Protocol Deviations concerns, quality issues, and other items that require face to face interaction)
• Collect Site Regulatory Package (SRP) documents during the Qualification Visit (QV) and other visits as needed
• Establish site recruitment plan in collaboration with the site staff during QV; follow up and update recruitment at the Initiation Visit and Monitoring Visit
• Collaborate with and communicate with the CMA on site issues/actions prior to planned visits and during the course of the trial
• Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up response
• Generate visit/contact report in accordance with monitoring plan
• Manage and process Central File documents in accordance with company policy
• Ship relevant wet-ink signature documents to the Research Operations Assistant/Record Management Assistant or back to the site
• Attend audits/Regulatory Inspection if requested
• Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
• Complete routine departmental administrative tasks in a timely manner (e.g. timesheets, metrics, etc.)
• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacities)
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements and study specific procedures and training
• Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery
• Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files as per Central File Maintenance Plan
• Escalate any site and study issues that require immediate action to the Functional Lead
Candidate Profile
Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred).
Minimum Work Experience: 3-4 years of on-site monitoring experience.
Language Skills: Advanced written and oral English.
Additional Information:
Experience: 3-4 years
Location: India
Functional Area: CR
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 25th October, 2017
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