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
Qualifications :
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.
Read More
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
Qualifications :
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.
Read More
from Trinity Publishing House http://ift.tt/1pebTjp
via IFTTT
Subscribe to us
100% Free.
Get It
close
No comments:
Post a Comment