Clinical Research Associate: Diagnostics, IVD
Clinical Research Associate: Diagnostics/IVD
Roswell, GA, US
Scientific
Bachelors Degree
Full Time, Temporary
50-70/hr
Experienced (Non-Manager)
Remote
Job Description:
Kelly® Science & Clinical is seeking a CRA for a full-time, contract-to-hire opportunity with a Biotech Company in Atlanta, GA. If you are passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
• Contract Clinical Research Associate
• This role is remote with high travel. Must be near a major airport, in the Central or Pacific time zone.
• This contract time frame is approximately nine (9) months to one (1) year with the possiblity of subsequent full-time employment.
Overview:
Our client is a well-funded startup medical device company early in its development that is seeking an experienced, ambitious, enthusiastic clinical research associate (CRA) to join our growing team. The role of the CRA is to ensure clinical studies are conducted in compliance with FDA regulations and ICH guidelines. The CRA will be involved in all investigational stages of the clinical trial, including identifying site(s); and setting up, initiating, monitoring and closing the trial upon completion or termination. The CRA is encouraged to have and strong organizational skills, interpersonal and team participation skills.
Responsibilities:
• Perform study start up activities which includes the regulatory document collection, review and approval process for IRB submission
• Prepare site regulatory binder
• Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites
• Audit the eTMF to ensure that regulatory documents are complete and accurate and audit ready
• Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects
• Verify adequacy, completeness, reliability, and quality of trial data collected at study sites
• Conduct site qualification, site initiation, interim monitoring and close out visits
• Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently
• Commute clear, concise information to the sponsor in a timely manner
• Participate in the preparation or creation of study related materials
The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.
Experience:
Strong organizational skills, interpersonal and team participation skills are essential. Working understanding of renal and cardiac therapeutic areas and ICU experience is a plus. The CRA must have the ability to effectively operate in a small company environment with potential fast future growth.
Qualifications:
• Bachelor’s degree in life sciences or a healthcare field
• 2+ years of relevant experience or an advanced degree with a minimum of 2 years relevant experience, including on-site monitoring.
• Prior experience in clinical trials with medical devices
• Clinical research certification preferred.
• The ability to perform travel up to an average of 80%, depending on project needs
• Extensive experience in clinical research settings
• Proficient with scientific software, including clinical trial management systems (CTMS), electronic data capture systems (EDC), and electronic trial master files (eTMF)
• Proficient with database software such, Microsoft Access, SharePoint and electronic medical records (EMR)
• Ability to work independently and manage multiple projects
• Detail-oriented; able to perform complex tasks with a high degree of accuracy
• Superior deductive reasoning, problem-solving, and decision-making abilities
• Excellent time management; able to prioritize tasks and accomplish set goals efficiently
• Strong written and oral communication skills
• As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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Apply tot his job
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Roswell, GA, US
Scientific
Bachelors Degree
Full Time, Temporary
50-70/hr
Experienced (Non-Manager)
Remote
Job Description:
Kelly® Science & Clinical is seeking a CRA for a full-time, contract-to-hire opportunity with a Biotech Company in Atlanta, GA. If you are passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
• Contract Clinical Research Associate
• This role is remote with high travel. Must be near a major airport, in the Central or Pacific time zone.
• This contract time frame is approximately nine (9) months to one (1) year with the possiblity of subsequent full-time employment.
Overview:
Our client is a well-funded startup medical device company early in its development that is seeking an experienced, ambitious, enthusiastic clinical research associate (CRA) to join our growing team. The role of the CRA is to ensure clinical studies are conducted in compliance with FDA regulations and ICH guidelines. The CRA will be involved in all investigational stages of the clinical trial, including identifying site(s); and setting up, initiating, monitoring and closing the trial upon completion or termination. The CRA is encouraged to have and strong organizational skills, interpersonal and team participation skills.
Responsibilities:
• Perform study start up activities which includes the regulatory document collection, review and approval process for IRB submission
• Prepare site regulatory binder
• Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites
• Audit the eTMF to ensure that regulatory documents are complete and accurate and audit ready
• Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects
• Verify adequacy, completeness, reliability, and quality of trial data collected at study sites
• Conduct site qualification, site initiation, interim monitoring and close out visits
• Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently
• Commute clear, concise information to the sponsor in a timely manner
• Participate in the preparation or creation of study related materials
The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.
Experience:
Strong organizational skills, interpersonal and team participation skills are essential. Working understanding of renal and cardiac therapeutic areas and ICU experience is a plus. The CRA must have the ability to effectively operate in a small company environment with potential fast future growth.
Qualifications:
• Bachelor’s degree in life sciences or a healthcare field
• 2+ years of relevant experience or an advanced degree with a minimum of 2 years relevant experience, including on-site monitoring.
• Prior experience in clinical trials with medical devices
• Clinical research certification preferred.
• The ability to perform travel up to an average of 80%, depending on project needs
• Extensive experience in clinical research settings
• Proficient with scientific software, including clinical trial management systems (CTMS), electronic data capture systems (EDC), and electronic trial master files (eTMF)
• Proficient with database software such, Microsoft Access, SharePoint and electronic medical records (EMR)
• Ability to work independently and manage multiple projects
• Detail-oriented; able to perform complex tasks with a high degree of accuracy
• Superior deductive reasoning, problem-solving, and decision-making abilities
• Excellent time management; able to prioritize tasks and accomplish set goals efficiently
• Strong written and oral communication skills
• As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Ke
Apply tot his job
Apply To this Job