Lead, Clinical Research Associate

Responsibilities Oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies. Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies executed at the sites. Direct supervision/line management of CRA staff and contractors in accordance with Celerion policies and applicable regulations. Interview, hire, and conduct onboarding training for new staff. Prepare and implement function-specific training programs and ensure adherence to Celerion’s procedures and guidance documents. Assign staff members to clinical projects and monitor staff workload. Ensure timely submission of timesheets and expense reports by staff. Develop, mentor, manage and coach CRA staff to progress their skills. Perform annual appraisals, define performance objectives and advocate individual career development. Serve as escalation line for direct reports including troubleshooting and issue escalation. Generate action plans and provide oversight to optimize monitoring services. Maintain a positive, results-oriented work environment and model teamwork. Support day-to-day execution of monitoring services for ongoing projects. Ensure deliverables of the CRAs assigned to the projects are met on time within quality and budget parameters. Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary. Participate in audits and inspections, including preparation activities. Requirements Bachelor's degree in a biomedical-related field, life sciences or equivalent field; At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience; People Management skills required; Excellent oral and written communication skills in English; High level of organization, multi-tasking, judgement , and analytical skills; Good time management skills to ensure adherence to timelines; Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements; Dedication to quality and reliability; Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research; Ability to work well independently and as part of a team; Self-motivation; Maintain confidentiality of Subject data and Sponsor/Client information; Computer literate; Strong attention to detail while being tactful and diplomatic; Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements; Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits and in maintaining Trial Master Files and handling SAEs; Flexible and willing to drive to the Tempe, Arizona site for both pre-planned and impromptu meetings/visits. #J-18808-Ljbffr Jobtailor