Sr Clinical Medical Writer (Remote)

Job Title: Senior Clinical Research Associate Department: QA Clinical Manager/Supervisor: Senior Manager, Clinical Affairs FLSA Status: Exempt SOP Group: Clinical/Regulatory Position Overview: The Senior Clinical Research Associate is responsible for managing clinical monitoring activities for domestic and international studies as well as managing other related initiatives, as required. Responsibilities: • Manage study startup activities such as site selection, site qualification visits, and site activation. • Prepare site initiation visit material and lead the training for protocol and case report forms for all sites. • Lead the effort for User Acceptance Testing for the study database build. • Lead the effort to draft the study-specific monitoring plan. • Review study-related documents such as protocols, consent/assent forms, etc. • Serve as the primary contact for questions related to protocol compliance throughout the study. • Conduct regular monitoring visits to ensure studies are being executed in compliance with the protocol, and applicable regulations. • Mentor other CRAs on the team. • Manage project meetings related to monitoring activities. • Lead study closeout and database lock activities. • Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines. • Performs other duties as required. Education and Experience: • B.S. or B.A. and/or an equivalent combination of education or experience. • CRA certification • Minimum of 5 years of monitoring 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 skills, be detail-oriented and have good interpersonal skills. • Knowledge of agency guidelines and requirements. Skills/Competencies: • Excellent written and effective verbal communication skills. • Ability to communicate at all levels of an organization. • Ability to effectively resolve site management issues of varying complexities. • PC skills; Microsoft Office, 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. Remote: 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). #LI-Remote Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $101,925.00 - $152,887.50 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. 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. (Know Your Rights) Apply tot his job