Clinical Research Associate - Remote
The responsibility of a Sr. Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. Responsibilities include 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.
Key Accountabilities
Function as mentor and role model for other CRA team members to ensure study specific training for CRAs
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 patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (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
Collaborate with CMA on site issues/actions
Recognize out of scope activities, escalate and communicates to GRO Lead
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
Attend audits / Regulatory Inspection if requested
Experience
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
Gives others appropriate latitude to make decisions
Carefully weighs the priority of project tasks and directs team accordingly
Understands the strengths and development areas of team members
Enlists the support of team members in meetings goals
Ability to successfully work in a team environment
Ability to lead a virtual, global team as required
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 up to 65% on average
Holds a driving license where required
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 monitoring experience or equal experience in clinical research
Estimated Salary: $20 to $28 per hour based on qualifications.
Key Accountabilities
Function as mentor and role model for other CRA team members to ensure study specific training for CRAs
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 patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (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
Collaborate with CMA on site issues/actions
Recognize out of scope activities, escalate and communicates to GRO Lead
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
Attend audits / Regulatory Inspection if requested
Experience
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
Gives others appropriate latitude to make decisions
Carefully weighs the priority of project tasks and directs team accordingly
Understands the strengths and development areas of team members
Enlists the support of team members in meetings goals
Ability to successfully work in a team environment
Ability to lead a virtual, global team as required
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 up to 65% on average
Holds a driving license where required
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 monitoring experience or equal experience in clinical research
Estimated Salary: $20 to $28 per hour based on qualifications.
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