Lead, Clinical Research Associate

Jobtailor; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor is seeking an experienced Clinical Operations Leader to oversee monitoring and site management for clinical trials and investigations at our Tempe, AZ site.

You will lead a team of Clinical Research Associates, supervise CRA staff and contractors, and drive training, onboarding and career development. Excellent English communication and strong regulatory knowledge are essential for success in this role.

Qualifications

• Bachelor's degree in biomedical-related field, life sciences or equivalent.
• At least 5 years in clinical operations or related discipline with minimum 3 years onsite monitoring experience.
• Proven people-management skills and leadership capability.
• Excellent oral and written English communication skills.
• Strong organizational, multitasking, and analytical abilities.
• Proficiency with Good Clinical Practice and 21 CFR Part 11 requirements.
• Commitment to continuous training and knowledge sharing.

Responsibilities

• Oversee monitoring and site management activities for clinical trials and investigations.
• Provide leadership to a team of CRAs at the sites.
• Direct supervision of CRA staff and contractors per policies and regulations.
• Interview, hire and onboard new staff; deliver function-specific training.
• Assign staff to projects and monitor workload; ensure timesheets and expenses are submitted on time.
• Mentor, coach and develop CRA staff; conduct annual appraisals and career development planning.
• Serve as escalation point for staff; drive action plans to optimize monitoring services.
• Interact with Sponsor/Client; participate in sponsor meetings and audits/inspections.

Skills

People management

English communication

Organization

Time management

GCP knowledge

Regulatory knowledge

Independent worker

Education

Bachelor's degree in biomedical/life sciences

Job description

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.