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Senior Clinical Research Specialist

In Minnesota / United States

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Senior Clinical Research Specialist   

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JOB TITLE:

Senior Clinical Research Specialist

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Plymouth Minnesota / United States

JOB DESCRIPTION:

Senior Clinical Research Specialist
Pay Rate: $49.76/HR

Cortech is seeking a Senior Clinical Research Specialist in Plymouth, MN.


As Senior Clinical Research Specialist, you will participate in the development of clinical evidence
generation plans that describe the strategy, anticipated scope and projected timelines to develop all the
clinical evidence needed to support a product/product family through its full lifecycle. This plan will
outline the steps to establish feasibility, achieve regulatory approvals and meet ongoing regulatory
requirements, gain reimbursement and support full commercial adoption. You will support the analysis
and interpretation of scientific data and write clinical study protocols, reports and scientific publications.
In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams,
including Marketing, R&D, Risk Management, Reimbursement, Medical Affairs, Quality and Regulatory
Affairs. You will also interact with global regulatory agencies to obtain market approval of new products
and study sites to train on study protocols, obtain Ethics Committee / IRB approval and respond to
questions throughout the study.


Primary Duties and Responsibilities
? Comply with applicable Corporate and Divisional Policies and procedures.
? Support the development of clinical strategy and study design.
? Write study protocols, study reports, and scientific papers for publication by evaluating scientific
literature, analyzing scientific data and staying abreast of current clinical practice.
? Support regulatory submissions
? Facilitate communication between Sales and Marketing, R&D, Program Management,
Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and
investigational sites.
? Oversee study Steering Committees and Publication Committees, consisting of physician Key
Opinion Leaders globally.
? Present clinical study results at investigator meetings
? Participate in and support audits.
? Participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.


Required Qualifications:
? Bachelor’s degree in engineering, medicine, healthcare or sciences
? 5+ years of clinical research work experience
? Demonstrated understanding of business environment and relates extensive knowledge of
internal and external technological activities to trends.
? Ability to participate in the development of other technical contributors by facilitating training
and providing feedback and guidance.
? Ability to plan and organize project assignments of substantial variety and complexity.
? Requires ability to be innovative, resourceful, and work with minimal direction
? Requires excellent organization, problem solving, and communication skills and the ability to
work effectively with cross-functional teams

Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

Health Care

SNAPRECRUIT ID:

S16204861025606861

LOCATION:

Minnesota / United States

CITY:

Plymouth

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Senior Clinical Research Specialist    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Senior Clinical Research Specialist
Pay Rate: $49.76/HR

Cortech is seeking a Senior Clinical Research Specialist in Plymouth, MN.


As Senior Clinical Research Specialist, you will participate in the development of clinical evidence
generation plans that describe the strategy, anticipated scope and projected timelines to develop all the
clinical evidence needed to support a product/product family through its full lifecycle. This plan will
outline the steps to establish feasibility, achieve regulatory approvals and meet ongoing regulatory
requirements, gain reimbursement and support full commercial adoption. You will support the analysis
and interpretation of scientific data and write clinical study protocols, reports and scientific publications.
In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams,
including Marketing, R&D, Risk Management, Reimbursement, Medical Affairs, Quality and Regulatory
Affairs. You will also interact with global regulatory agencies to obtain market approval of new products
and study sites to train on study protocols, obtain Ethics Committee / IRB approval and respond to
questions throughout the study.


Primary Duties and Responsibilities
? Comply with applicable Corporate and Divisional Policies and procedures.
? Support the development of clinical strategy and study design.
? Write study protocols, study reports, and scientific papers for publication by evaluating scientific
literature, analyzing scientific data and staying abreast of current clinical practice.
? Support regulatory submissions
? Facilitate communication between Sales and Marketing, R&D, Program Management,
Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and
investigational sites.
? Oversee study Steering Committees and Publication Committees, consisting of physician Key
Opinion Leaders globally.
? Present clinical study results at investigator meetings
? Participate in and support audits.
? Participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.


Required Qualifications:
? Bachelor’s degree in engineering, medicine, healthcare or sciences
? 5+ years of clinical research work experience
? Demonstrated understanding of business environment and relates extensive knowledge of
internal and external technological activities to trends.
? Ability to participate in the development of other technical contributors by facilitating training
and providing feedback and guidance.
? Ability to plan and organize project assignments of substantial variety and complexity.
? Requires ability to be innovative, resourceful, and work with minimal direction
? Requires excellent organization, problem solving, and communication skills and the ability to
work effectively with cross-functional teams


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