Principal Clinical Research Associate (Remote / Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Job Title: Principal Clinical Research Associate

Department: QA Clinical

Manager/Supervisor: Senior Manager, Clinical Affairs

FLSA Status: Exempt

SOP Group: Clinical/Regulatory

Position Overview

The Principal Clinical Research Associate is responsible for the oversight of all study site related activities for domestic and/or international studies as well as managing other related initiatives, as required with support from the Senior Manager of Clinical Affairs

Responsibilities

• Oversee all study startup activities such as site selection, site qualification visits, and site activation to ensure acceptability of qualified investigative sites.
• Oversee all study specific training requirements (both internally and externally).
• Oversee the creation, implementation and maintenance of the study-specific monitoring plan and other site related documents including informed consent, training materials, case report forms, source worksheets, device accountability, agreements, delegation of authority log, etc.
• Review all study related documents such as protocols, data management plan, risk management plan, safety management plan etc. to ensure compliance with requirements across all study sites.
• Be the primary point of contact for study related questions throughout the study to ensure alignment globally between all monitors and sites.
• Support protocol deviations and adverse event reviews for timely reporting and acts as the primary liaison between other functions as needed such as medical monitor, data management, and post-market surveillance.
• Conduct audits of study files and sites globally to ensure compliance with the protocol and other study requirements, standard operating procedures, and regulatory requirements. Ensure study files and sites are always inspection ready.
• Serves as initial point of escalation for sites and monitors/CRA and supports the monitoring of sites as needed with ability to manage complex studies and/or challenging sites. Apply root cause analysis, critical thinking and problem-solving skills to identify site process failures and corrective/preventative actions to bring the site into compliance or decrease risk.
• Escalates significant deficiencies and issues to clinical management expeditiously, supports resolutions and follows all issues through to resolution.
• Provide updates on potential trends noted across multiples sites and implement strategies for necessary changes or improvements.
• Develop and manage monitoring schedules to ensure appropriate monitoring cadence of study sites in accordance with the monitoring plan and ensure all activities are completed. Review monitoring reports from other monitors and ensure monitoring reports and all activities are conducted within the specified timeframes.
• Lead project team meetings related to monitoring activities.
• Oversee the execution of study closeout and database lock activities to ensure accurate, consistent, high-quality data.
• Participate in the evaluation and selection of potential vendors.
• Mentor and train other CRAs on the team.
• Assist with developing procedures and process improvements/efficiencies.
• Performs other duties as assigned (note, all listed tasks may not be required depending on study status and roles of other internal and external team members).
  
  

Education And Experience

• B.S. or B.A. degree required.
• Minimum of 12+ years of direct experience in the execution of clinical research studies including monitoring.
• Available to travel (up to 60%) on short notice and independently manage travel schedules.
• Must have analytical skills, be detail-oriented and have good interpersonal skills.
• Knowledge of all regulatory guidelines and regulations.
  
  

Skills/Competencies

• Excellent written and verbal communication skills.
• Ability to communicate at all levels of an organization and with sites including physicians.
• Ability to effectively resolve site management issues of varying complexities.
• PC skills: proficient in Microsoft Office, spreadsheets and various databases.
• Flexible and able to work in a fast-paced environment and develop creative solutions to meet goals while maintaining compliance.
• Team player and able to lead in a positive manner.
• Ability to organize and judge priorities and assist other monitors in prioritizing tasks.
• Excellent ability to generate and maintain accurate records.
  
  

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).

Additional Information

The US base salary range for this full-time position is $113,600.00 - $170,750.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

(Know Your Rights)