Senior Clinical Research Associate



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The responsibility of a 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. Responsible for coordinating a moderate to large team or multiple small size protocols as the CRA Coordinator, with minimal to no supervision. Alternatively, take on the role of a CRA Coordinator on smaller projects. • Assume the ability to meet the requirements of a CRA I and II with a high degree of proficiency and autonomy • Shows solid understanding of therapeutic indications and study hypothesis. • Act as an independent CRA Coordinator on complex or multiple projects, CRA Coordinator on smaller projects • Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent PAREXEL at professional meetings / conferences • 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

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 • 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
Additional Information
Location | | | Home Based Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013

Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided


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