Sr Clinical Research Spec

Pay: $45–55/hour depending on experience

About the Role

HM’s top needs: 3 or more years of clinical research experience with an industry sponsor. Preferred experience in medical devices. Experience with site activation and site management activities.

Education Required: Bachelor’s degree

Years’ Experience Required: 3 or more

Work Location: Preferably on-site in the Minnesota office (alternatives could be Colorado and Irvine). Given the option to convert to a non-vendor employee, in-office work will be required.

Responsibilities

• Oversees, designs, plans, and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that satisfy a medical need and/or offer commercial potential.
• Oversees and interprets results of clinical investigations in preparation for new drug, device, or consumer applications.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
• May prepare clinical trial budgets, manage clinical supply operations, and handle site and vendor selection.
• Other duties as assigned.

Role Characteristics

Specialist Career Stream: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with stakeholders to achieve desired results. May act as a mentor to colleagues or direct the work of lower-level professionals. The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills acquired through advanced education.

Differentiating Factors:

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop solutions. Coaches and reviews the work of lower-level specialists; may manage projects or processes.
• Organizational Impact: May be responsible for entire projects or processes within the job area. Contributes to the completion of work group objectives by building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple job areas or specialties. Makes improvements to processes, systems, or products to enhance performance. Analysis is in-depth and often includes recommendations for process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information, facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
• Leadership and Talent Management: May provide guidance, coaching, and training to other employees. May manage projects, requiring delegation of work and review of others' work products.

Requirements

• Advanced knowledge of job area, combining breadth and depth, typically obtained through advanced education combined with experience.
• May require practical knowledge of project management.
• University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.