Clinical Research Spec- Site Management

Job Title: Clinical Research Spec- Site Management
Location: Mounds View, MN 55112
Contract Length: 24 Months+ (Possible Extension)

Shift: 1st Shift.

Pay range: $30 - $40/hr. on W2.
 
Top Needs:

• Site management experience (site or sponsor).
• Knowledge/experience with CTMS/EDC/TMF.
• Experience with Good Clinical Practice (GCP).

 
Education Required: Bachelor’s degree.
Years of Experience Required: Minimum 2 years.
Work Schedule: 40 hours/week.
 
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 determined to 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.
• May be responsible for clinical supply operations, site and vendor selection.

 
Specialist Career Stream:

• Typically an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages assigned projects and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or direct the work of lower-level professionals.
• Majority of time spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

 
Differentiating Factors:
 
Autonomy:

• Established and productive individual contributor.
• Works independently with general supervision on larger, moderately complex projects/assignments.

Organizational Impact:

• Sets objectives for own job area to meet project objectives.
• Contributes to completion of project milestones.
• May have involvement in cross-functional assignments.

 
Innovation and Complexity:

• Problems and issues are general and may require understanding of broader issues or other job areas.
• Typically not complex.
• Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

 
Communication and Influence:

• Communicates primarily with internal contacts.
• External interactions are less complex or problem-solving in nature.
• Contacts others to share information, status, needs, and issues to inform, provide input, and support decision-making.

 
Leadership and Talent Management:

• May provide guidance and assistance to entry-level professionals and/or employees in Support Career Stream.

 
Required Knowledge and Experience:

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Requires a University degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.