Clinical Research Specialist

Clinical Research Specialist

14 sep
|
Medtronic
|
Departamento de Santa Rosa

14 sep

Medtronic

Departamento de Santa Rosa

The Senior Clinical Research Specialist oversees, designs, plans and develops clinical evaluation projects. Conducts clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. May assumes project management responsibility for selected studies as a clinical study leader.

POSITION RESPONSIBITIES
Responsible for overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Drives process to determine study objectives, strategy, scope, and schedule in order to meet business needs; may include development of global clinical and reimbursement strategies.




• Participates in and may lead creation of clinical study management plan, protocol and case report form development.
• Assists in preparation of study materials and/or training.
• Evaluates clinical data and writes clinical reports.
• Drives resolution and follow-up of site issues.
• Provides support and training for clinical study sites to ensure data integrity and protocol compliance.
• Assist data management group with review of clinical data/information and oversight of data correction..
• May interface with representatives from key functional groups including Product Development, Manufacturing, Distribution, Marketing, and Regulatory Affairs.
• Drives site level study closure activities.
-Develop and manage study budget
• Accountable for maintaining accurate clinical study files.
• Able to refer to Standard Operating Procedures (SOPs) and study management process for guidance on everyday study tasks.
• Assists clinical management with other duties as requested.
• Assist in control of device allocation, distribution and reconciliation. 
• May oversee activities performed by Contract Research Organizations (e.g. CROs, core labs). 
• Provide work direction to Project Coordinator(s) and CRS(s)  

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

• Bachelor’s degree
• Working knowledge of Good Clinical Practice (GCP) and regulations for clinical trials.

EDUCATION REQUIRED: 
• 4+ years experience directly supporting clinical research or relevant experience in medical/scientific area.
• Masters degree will substitute for 1 year of experience.  PhD or MD will substitute for 2 years of experience.

DESIRED/PREFERRED QUALIFICATIONS 
• Strong written, oral, and interpersonal communication skills.
• Computer skills (MS Office products, word processing, spreadsheets, etc.)
• High attention to detail and accuracy
• Ability to manage multiple tasks in a fast-paced environment
• Good prioritization and organizational skills
• Excellent problem solving skills
• Positive outlook
• Flexible and dependable
• Works effectively on cross-functional teams
• Project management skills
• Proficient knowledge of medical terminology.


The physical demands described within the Responsibilities section of this job description are representative of those 
that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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