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We are currently hiring for CRA II (minimum of 2 solid years of experience) and Sr. CRA (minimum 5 years of solid experience)

Essential Function

The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. 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

  • Assume the ability to meet the requirements of a CRA I with a high degree of proficiency and autonomy
  • Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
  • Train team members on selected tasks
  • Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.
  • 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
  • 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
  • Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead
  • 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


About Precept Life Sciences:

Precept Life Sciences is a premier professional workforce solutions firm headquartered in Sterling, Virginia. Established in 1999, Precept possesses a proven track record of providing key talent for the dynamic Life Science industry within North America. With over 70 years of combined recruiting experience, our team consists of degreed scientists who quickly comprehend complex technical requirements, enabling us to accurately identify the right talent for you. Precept specializes in supporting the Pharmaceutical, Biotech, Medical Device, CMO/CRO industries within the following skill sets. From single placements to comprehensive workforce solutions projects, Precept is committed to offering the right-sized solution for our customers. Simply put, we strive to be your most valued resourcing partner operating within our core values; Integrity, Excellence, Expertise, Results.

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