Clinical Research Spec

Planet Pharma; Coon Rapids (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

Planet Pharma is seeking a Clinical Research Associate to support planning and execution of clinical studies, including site management, study documentation, data review, and coordination with internal and external stakeholders. This role reports to a Clinical Study Manager and ensures adherence to SOPs, GCP, and regulatory requirements.

Responsibilities may include start-up/closeout activities, maintaining clinical systems and documentation, and liaising with sites and vendors within the region.

Qualifications

• Bachelor's degree required.
• 1-2 years of relevant clinical research experience.
• Willing to work 40 hours per week.

Responsibilities

• Oversee, design, plan and develop clinical evaluation research studies.
• Prepare and author protocols and patient record forms.
• Conduct registered and non-registered clinical studies of products with medical need or commercial potential.
• Oversee and interpret results of clinical investigations for new drug, device or consumer applications.
• Manage operational aspects of clinical trials with project teams and SOPs, GCP and country regulations.
• May manage clinical supply operations, site and vendor selection.
• Represent the company in clinical research activities within the region and engage with local customers and authorities.
• Build and maintain relationships with internal and external stakeholders and drive local evidence dissemination.

Education

Bachelor's degree

Tools

CTMS

EDC

TMF

Job description

HM’s Top Needs:

1. Site management experience, either at a clinical site or sponsor.
2. Experience with clinical systems such as CTMS, EDC, and TMF.
3. Knowledge of and experience with Good Clinical Practice (GCP) and clinical trial regulatory requirements.

   The position will support the planning and execution of clinical research studies, including site management activities, study documentation, data review, and coordination with internal and external stakeholders. The individual will work under the direction of a Clinical Study Manager and help ensure studies are conducted in accordance with applicable SOPs, Good Clinical Practice (GCP), and regulatory requirements. Responsibilities may also include supporting study start-up and closeout activities and maintaining clinical systems and documentation.

Education Required: Bachelors

Years’ Experience Required: 1-2yr +

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours per week

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