The responsibility of a Senior Clinical Research Associate (SCRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. Responsibilities including performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines. May have additional leadership responsibilities including coordinating a moderate to large team or multiple small size protocols with minimal to no supervision.
Key Accountabilities
• Assume the ability to meet the requirements of a CRAI and II with a high degree of proficiency and autonomy.
• Shows solid understanding of therapeutic indications and study hypothesis.
• Function as mentor and role model for other CRA team members to ensure study specific training for CRAs.
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations.
• Perform co-monitoring visits with less experienced CRAs or at problem sites as required.
• 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 and maintain ICH-GCP compliance.
• Responsible for the completeness and quality of the on-site files.
• Respond to site issue alerted from project team (i.e. non-responsive site, Protocol Deviations concerns, and quality issues etc., items that require face to face interaction).
• Collect Statutory Regulatory Package 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 systems on an ongoing basis.
• Collaborate with CMA on site issues/actions.
• Generate visit/contact report in accordance with monitoring plan.
• Escalate all issues that require immediate action to the Project Leader
• Code and scan Central File documents where applicable.
• Ship relevant wet-ink signature documents to the Assistant or back to the site.
• Attend audits / Regulatory Inspection if requested.
• Complete all routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel, expense reports)
• Additional Leadership Responsibilities may include:
o Act as an independent CRA Coordinator on complex or multiple projects, CRA Coordinator on smaller projects.
o Recognize out of scope activities, escalate and communicate to Study Team.
o Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required.
o Take responsibility for specific tasks on projects, or act as the main CRA contact on individual projects.
o Provide feedback in formal staff review process in conjunction with Line Management
Qualifications :
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.
• Looks for win-win solutions to solve problems.
• Carefully weighs the priority of project tasks and directs team accordingly.
• A flexible attitude with respect to work assignments and new learning
• Ability to successfully work in a team environment.
• Sound presentation skills.
• Consultative skills.
• Ability to make appropriate decisions in ambiguous situations.
• Ability to solve problems by using a logical, systematic, sequential approach.
• Client focused approach to work with the ability to interact professionally within a client organization.
• Ability to prioritize multiple tasks and achieve project timelines.
• Effective time management in order to meet daily metrics or team objectives.
• Shows commitment to and performs consistently high quality work.
• 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.
• Advanced Leadership Skills to include the following skills
o Ability to lead a “virtual”, global team as required.
o Understands the strengths and development areas of team members.
o Enlists the support of team members in meeting goals.
o Gives others appropriate latitude to make decisions.
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
• Substantial monitoring experience or equal experience in clinical research
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Key Accountabilities
• Assume the ability to meet the requirements of a CRAI and II with a high degree of proficiency and autonomy.
• Shows solid understanding of therapeutic indications and study hypothesis.
• Function as mentor and role model for other CRA team members to ensure study specific training for CRAs.
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations.
• Perform co-monitoring visits with less experienced CRAs or at problem sites as required.
• 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 and maintain ICH-GCP compliance.
• Responsible for the completeness and quality of the on-site files.
• Respond to site issue alerted from project team (i.e. non-responsive site, Protocol Deviations concerns, and quality issues etc., items that require face to face interaction).
• Collect Statutory Regulatory Package 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 systems on an ongoing basis.
• Collaborate with CMA on site issues/actions.
• Generate visit/contact report in accordance with monitoring plan.
• Escalate all issues that require immediate action to the Project Leader
• Code and scan Central File documents where applicable.
• Ship relevant wet-ink signature documents to the Assistant or back to the site.
• Attend audits / Regulatory Inspection if requested.
• Complete all routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel, expense reports)
• Additional Leadership Responsibilities may include:
o Act as an independent CRA Coordinator on complex or multiple projects, CRA Coordinator on smaller projects.
o Recognize out of scope activities, escalate and communicate to Study Team.
o Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required.
o Take responsibility for specific tasks on projects, or act as the main CRA contact on individual projects.
o Provide feedback in formal staff review process in conjunction with Line Management
Qualifications :
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.
• Looks for win-win solutions to solve problems.
• Carefully weighs the priority of project tasks and directs team accordingly.
• A flexible attitude with respect to work assignments and new learning
• Ability to successfully work in a team environment.
• Sound presentation skills.
• Consultative skills.
• Ability to make appropriate decisions in ambiguous situations.
• Ability to solve problems by using a logical, systematic, sequential approach.
• Client focused approach to work with the ability to interact professionally within a client organization.
• Ability to prioritize multiple tasks and achieve project timelines.
• Effective time management in order to meet daily metrics or team objectives.
• Shows commitment to and performs consistently high quality work.
• 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.
• Advanced Leadership Skills to include the following skills
o Ability to lead a “virtual”, global team as required.
o Understands the strengths and development areas of team members.
o Enlists the support of team members in meeting goals.
o Gives others appropriate latitude to make decisions.
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
• Substantial monitoring experience or equal experience in clinical research
pare-10037103
Read More
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