Clinical Studies Specialist IV

We are looking for a Clinical Studies Specialist IV for a 12 months contract position in Neenah, WI.

Leads, designs, plans, and monitors all clinical trial phases to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice. 

SKILLS:

- Experience in Project management 

Experience in clinical research 
Business communication skills 
Knowledge of device/pharmaceutical regulations (510K, PMA) - Required, as a minimum, a Bachelor's degree in Nursing and a minimum of 1 year of work experience in clinical research operations. Relevant experience or education may be substituted.
- Demonstrated ability to critically assess, discuss, and present clinical research study protocols and data.
- Strong leadership and positive interpersonal skills and problem solving abilities.
- Excellent oral, written, and organizational skills and demonstrated experience with developing and executing clinical research protocols.
- Ability to effectively handle multiple projects with competing timelines in a fast-paced environment.
- Experienced in developing clinical research protocols, informed consents and other applicable documents for submission to external Institutional Review Boards.
- Proficient in Microsoft Office applications eg, Word, PowerPoint, Excel and Outlook.
- Possess a basic understanding of statistical methods.

PREFERRED QUALIFICATIONS:

- A Master's degree in Nursing or health related field.
- Certification specific to clinical or regulatory organization.
- 2-5+ years of experience in clinical research and thorough understanding of GCPs

RESPONSIBILITIES:

- Leads clinical project teams and represents clinical affairs on multi function projects teams internally/externally 

Assist in the design of clinical protocols and trial case report forms 
Oversees external consultants including contract research organizations and Clinical Research Associates. 
Responsible for providing trial status updates to project teams and management. 
Responsible for clinical study budgets. - Design and manage clinical studies to support various internal customer projects.
- Train and oversee clinical study coordinators to ensure compliance with study protocol.
- Advise and direct others on developing clinical study protocols and options to mitigate risks to human subjects.
- Implement appropriate clinical research site procedures related to clinical study development and execution.
- Mentor all team members in responsible, ethical conduct of research with human subjects.
- Contribute to an environment in which all team members are respected regardless of their individual differences, and are motivated to improve both their individual and team contributions to achieve desired business results.

Please email.