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.