What are we looking for in our Clinical Trial Lead / Study Lead?

The Scientific Team at Russell Tobin & Associates is supporting an exciting medical device organization that has an opening for a Remote Clinical Trial Lead / Study Lead

Responsibilities

• Establish, track and deliver clinical operations milestones
• Provide direction and leadership to the clinical operations study team
• Will act as single point of accountability for all stages of clinical operations activities (early study design, start-up, active study, and close-out)
• Collaborate with internal teams
• Identify risks that may impact the project
• Develop/revise and/or provide input in the development of clinical trial related documents
• Lead strategy discussion

Requirements:

• Bachelor's, Masters or PhD in technical / scientific discipline
• Must have experience in trial design and preparation (Drafting/authoring study protocols, training materials, case report forms, informed consents, IRB submissions, source documents, timelines, clinical monitoring plans, reference manuals, supply listings, monitoring tools, presentations, meeting materials (agenda and minutes)

• Site management, site qualification, monitoring and close out experience required
• Must have prior experience in a similar role 8-12 years expeirence in medical device, pharma, IVD and/or CRO
• 5-8 years experience leading clinical study preparation and monitoring and leading study team
• Proven track record in clinical study completion with adherence to timelines, budget, and milestones
• In-depth knowledge of applicable clinical research guidelines and regulations
• Software, tool, system experience in CTMS, eCRF, TMF, etc.

Additional Details:

• Schedule: Monday-Friday
• Remote position - may require travel up to 25-30%
• Position type: 1-year contract
• Pay rate range approved $58-72/hr depending on experience

Must be authorized to work in the United States.

Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

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About Us

Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.

We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.

We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.

As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.

Rate/Salary: $58-72/hr