Job Description
Job Title: Clinical Research Associate
Department: QA Clinical
FLSA Status: Exempt
Position Overview:
The Clinical Research Associate is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required.
Responsibilities:
• Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study.
• Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.
• Create consent and assent templates specific to the needs of the planned study.
• Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent.
• Train site staff on protocol requirements, source documentation, and case report form completion.
• Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent/assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments.
• Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
• Coordinate project meetings.
• Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc.
• Participates in team meetings and tracks action items.
• Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Performs other duties as required.
Education and Experience:
Minimum Requirements:
• B.S. or B.A. and/or an equivalent combination of education or experience.
• CRA certification
• Minimum of 3 years of experience.
• Available to travel on short notice and independently manage travel schedules.
• Direct experience in participating in the execution of clinical research studies.
• Must have analytical skill, be detail oriented and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.
Preferred Skills/Competencies:
• Excellent written and effective verbal communication skills. Bilingual English and French is preferred
• Ability to communicate at all levels of an organization.
• PC skills; word processing, spreadsheet, database, Internet search and utilization.
• Flexible and able to work in a fast-paced environment.
• Team player.
• Ability to organize and judge priorities.
• Excellent ability to generate and maintain accurate records.
Other: 60%-70% Travel
• Ideal candidate will be able to work hybrid from our Acton, MA or San Diego, CA offices.
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely other days). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $85,575.00 - $128,362.50. 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.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
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!
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.
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Job Tags
Full time, Work at office, Local area, Remote work, Flexible hours,