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29 days old

Clinical Research Associate I

C3 Research Associates
Seattle, Washington

C3 Research Associates is currently seeking a full-time regional Clinical Research Associate (CRA). This is a home-based position in the United States.

C3 Research Associates is a full-service Seattle based clinical research organization (CRO). We focus on supporting clinical trials for small to mid-sized biotech, pharma and medical device companies in the early phases of clinical development. We are an employee-focused, niche service provider seeking highly skilled individuals to join our team.

For CRAs who are looking for a smaller company that puts the value of our employees first, we offer a competitive salary and innovative benefits package including an annual bonus, flexible PTO policy, a 401(k) and much more.

We are a group of dedicated, passionate people working in a fast-paced and supportive organization, who genuinely like each other and enjoy what we do. If you are an energetic and bright individual looking to make a career change where you can truly be a contributor, we want to hear from you!

Position Summary:

Responsible for conduct and management of the clinical monitoring function of clinical trials, both directly and working with contracted providers. This position focuses on coordination of all monitoring activities required to initiate, monitor and complete clinical programs.

Primary Responsibilities:

  • Conduct on-site visits (Qualification, Initiation, Interim, Close-Out) to monitor study progress and assure compliance with protocol-requirements, applicable regulations, ICH/GCP and Company Standard Operating Procedures.
  • Serve as primary contact for sites, Project Managers, Clinical Data Managers, and other staff as needed for site-related inquiries and issues.
  • Act as site liaison to Sponsor Representatives, Clinical Trial Managers, and Clinical Trial Associates.
  • Prepare timely, appropriate, and accurate communication to internal and external teams, investigative site staff, and consultants.
  • Manage and track study progress on recruitment/site selection, site readiness, regulatory (IRB/EC) submissions, subject enrollment, etc.
  • Participate in project calls and provide study updates as appropriate.
  • Lead or assist with study start-up activities including the review of clinical and project-related documents as requested by management.
  • Participate in Company or Sponsor required training programs.
  • Perform necessary administrative functions (e.g., tracking and submitting expense reports, time, and attendance).
  • Maintain home office (e.g., procurement of office supplies, submission of documents).
  • Perform other duties as assigned.

Qualifications:

  • Minimum of 3 years of related clinical research experience. At least 2 years of on-site monitoring experience and 1 year of oncology experience is preferred.
  • Previous experience in a small or start-up company with a remote work environment is desirable.
  • Bachelor’s degree in a life science or medical discipline, or equivalent applicable experience, is preferred.
  • Willingness and capable of traveling within North America (primarily Midwest and East Coast regions) or Foreign Territory (if applicable to project) for as much as 60% of time or as required by specific study/project needs.
  • Proficiency with Microsoft Office Suite, electronic data systems, and other database programs is required.
  • Must have the ability to work independently and maintain confidentiality.
  • Excellent verbal and written communication skills and the ability to communicate effectively with all levels. This position requires the ability to work with outside agencies in a professional manner.
  • Strong organizational skills.
  • Attention to detail and accuracy is essential.
  • A working knowledge of FDA regulations, ICH/GCP and other regulatory requirements.
  • Ability to work in a fast-paced environment.

Behavioral Competencies Required:

Must possess excellent interpersonal skills. Must have the ability to build and maintain positive relationships with management, colleagues, and study teams. Excellent written and verbal skills required. Must display strong analytical and problem-solving skills. Attention to detail required.

Physical Demands Required:

Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs. May encounter prolonged periods of sitting. To perform this job successfully, an individual must be able to perform each essential duty as outlined in the contract and/or work order satisfactorily.

The requirements listed above are representative of the knowledge, skills, and/or abilities required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and requirements.

Categories

Posted: 2018-11-15 Expires: 2018-12-15

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Clinical Research Associate I

C3 Research Associates
Seattle, Washington

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