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: Data Monitoring Associate
Job Description:
Essential Function
The responsibility of a Clinical Monitoring Associate (CMA) is to perform remote clinical monitoring tasks of designated projects in accordance with applicable SOP, regulations and ICH GCP guidelines. Responsibilities include managing/supporting clinical monitoring activities remotely, including issue resolution, collecting regulatory documentation, patient enrollment management, handling protocol- and/or ICF- and/or contract amendments, drug / supply management, and ensuring timely data entry at a site level. May perform remote qualification, initiation, monitoring and termination calls at investigational sites according to the protocol and sponsor requirements.
Key Accountabilities
• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL and/or Client SOPs and study specific procedures (e.g. Monitoring Plan)
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics)
• Take responsibility for specific tasks on projects, or acts as the main CMA contact on individual projects
• Create and distribute study documents
• Responsible for the completeness and quality of the in-house site specific files (in cooperation with ROA/RMA)
• Update all relevant tracking systems on an ongoing basis
• Maintain site staff details
• Perform regular reviews of data in the system according to data review/monitoring guidelines (CTMS, EDC, IVRS, etc.)
• Arrange and conduct remote visits (qualification, initiation, monitoring, termination)
• Generate contact reports in accordance with the monitoring plan
• Collect updated/amended regulatory documents in collaboration with CRA and CTS as needed
• Code and scan Central File documents where applicable
• Ship relevant wet-ink signature documents to the ROA/RMA
• Collaborate with CRA with site issues/actions
• May attend on-site visits to assist the CRA in co-monitoring if needed.
• Follow-up on appropriate site related questions and respond to site issues alerted by the project team (i.e, non-responsive site, quality issues etc., that can be addressed without face to face interaction)
• Monitor patient safety remotely (review for missing SAEs, AEs, ConMed) and address protocol violations
• Initial and ongoing drug/supply management
• Build relationships with investigators and site staff remotely
• Train site staff remotely on study-specific activities to improve compliance/performance.
• Participate in Investigator and other external or internal meetings as required.
• Inform responsible COL / Coordinator / Manager (as appropriate) of work status regularly
• Escalate any issues that require immediate action to the COL / Coordinator
• Recognize out of scope activities, escalate and communicate to the COL / Coordinator
• Keep manager informed about work progress and any issues to avoid surprises.
• Attend in-house audits / Regulatory Inspection if requested
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Skills
• Strong regulatory knowledge including GCP
• Client-focused approach to work, with the ability to interact professionally within a client organization
• Ability to successfully work in a (‘virtual’) team environment
• Excellent interpersonal, verbal and written communication skills
• Effective time management in order to meet daily metrics or team objectives
• A flexible attitude with respect to work assignments and new learning
• Able to take initiative and work independently, but seek guidance when necessary, escalating issues as required
• Sense of urgency in completing assigned tasks
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail to achieve project milestones
• Effectively apply knowledge to provide advice or solutions based on expertise.
• Show commitment to and perform consistently high quality work
• Strong computer and internet skills including knowledge of Clinical Trial Management Systems and EDC, MS-Office products such as Excel, Word.
• Sound presentation skills
• Analytical and consultative skills
• Ability to solve problems through win-win solutions by using a logical, systematic, sequential approach.
• Willing and able to travel as required, local or international
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, and relevant local languages
Minimum Work Experience
• Adequate previous monitoring experience (preferred), or data management, clinical and/or other research experience with solid understanding of clinical trials methodology and terminology.
Additional Information:
Location: India
Functional Area: Other
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 30th September, 2014
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