Lead, Clinical Research Associate - Arizona

Project related responsibilities

Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations. This includes, but is not limited to:

•Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows:

-Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs

-Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.)

-Co-monitor as needed

-Update and review of clinical trial management tracking systems (CTMS)

-Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened)

-Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors

-Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan

•Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary;

•Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues

•Participate and demonstrate proactive involvement in project study meetings, internal project study meetings, and other activities enhancing project progress

•Participate in audits and inspections, including preparation and follow-up activities as needed

•Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements.

•May act as a CRA for selected studies where needed and defined

Additional Responsibilities

•Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client

•Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)

•Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities

•Maintain a working knowledge of all required Celerion IT systems

•Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary

•Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates

•Perform other duties as assigned

Requirements and Qualifications

•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.