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8 days old

In-house CRA

Kelly Services
Jacksonville, FL 32232
Kelly Science & Clinical is currently seeking an **In-House CRA** for a long-term engagement with one of our Global Med Device clients out of Jacksonville, FL


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Summary:**

The In-House CRA III is based in the clients facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials.


**Responsibilities:**

Work to ensure that trials are adhere to study protocols, applicable sops, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (GCP) guidelines, and government regulations.

Evaluate, monitor, and document study results.

Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.

Monitor Clinical Research Organizations (CROs) and study management of multiple sites.

Additional duties include: document retrieval, archival, informed consent release forms, amendments, etc.

Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome.

Ensure procedures are in place for appropriate optimization of patients into the clinical trial.

Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.

Approximately 15% on-site monitoring (primarily local but including Southeast US).


**Qualifications**

Bachelors degree required

3+ years CRA medical device experience required

On-site monitoring experience required

Electronic Data Capture (EDC) experience required (non-discriminatory)

Excellent oral and written communication skills

Willingness to travel up to 15% (as-needed basis, not continuous basis) in Southeast US for intermittent monitoring


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-13 Expires: 2021-11-13

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In-house CRA

Kelly Services
Jacksonville, FL 32232

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