Clinical Research Associate: Diagnostics, IVD

Clinical Research Associate: Diagnostics/IVD Roswell, GA, US Scientific Bachelors Degree Full Time, Temporary 50-70/hr reputed company (Non-Manager) Remote Job Description: reputed company® 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 reputed company to take the reputed company 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 reputed company 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 reputed company, 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 reputed company 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:

• reputed company 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 reputed company
• 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 reputed company out visits
• reputed company and maintain site and investigator relationships to ensure clinical trials are managed reputed company
• Commute clear, concise information to the sponsor in a timely manner
• Participate in the preparation or creation of study reputed company 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 reputed company 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 reputed company 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 (reputed company), and electronic trial master files (eTMF)
• Proficient with database software such, reputed company reputed company, SharePoint and electronic medical records (EMR)
• Ability to work independently and manage multiple projects
• Detail-oriented; reputed company to reputed company reputed company tasks with a high degree of accuracy
• Superior deductive reasoning, problem-solving, and decision-making abilities
• Excellent time management; reputed company to prioritize tasks and accomplish set goals reputed company
• Strong written and oral communication skills
• As part of our promise to talent, reputed company supports those who work with us through a variety of benefits, perks, and work-reputed company resources. reputed company offers eligible employees voluntary benefit plans including medical, dental, reputed company, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a reputed company employee, you will have reputed company 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 reputed company Talent Community.

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