Clinical Research Specialist

Planet Pharma; Saint Paul (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma is seeking a Clinical Research Specialist in the United States to oversee and design clinical evaluation studies in alignment with SOPs and regulatory standards.

The role includes preparing protocols, authoring patient forms, conducting studies, and interpreting results for potential medical or commercial products. Collaboration with project teams and vendors is required.

Qualifications

• Practical knowledge in clinical research with demonstrated competence.
• Must meet regulatory requirements and SOP/GCP standards.
• Minimum 2 years of relevant experience in clinical research.

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 with potential medical or commercial value.
• Oversees and interprets results of clinical investigations for new drug, device, or consumer applications.
• Manages operational aspects of trials with project teams, SOPs, and country regulations; may prepare budgets.
• May handle clinical supply operations, site and vendor selection.
• Represents the company regionally in clinical research discussions and collects feedback from stakeholders.
• Builds relationships with internal and external parties and drives local evidence dissemination.

Skills

Clinical research

Regulatory compliance

SOP adherence

GCP knowledge

Project coordination

Education

Bachelor's degree

2 years relevant experience

Job description

Responsibilities may include the following and other duties may be assigned. 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 have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. 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, and may prepare clinical trial budgets. May be responsible for clinical supply operations, site and vendor selection. People working within region/country may also have the responsibilities that include: Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities. Builds and maitains optimal relationships and effective collaborations with various internal and external parties. Drives local evidence dissemination & awareness. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

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 the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are 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 and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee 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 Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience