Now hiring a Clinical Research Study Associate for Jacksonville FL to work directly for our well known pharma client. This opening can accept a Clinical Study Associate, Level 1 or 2, with clinical research exposure.
- Support investigative sites toward completion of all required clinical trial documents prior to site initiation. \t
- Create the regulatory binder with the requested essential documents collected for each clinical site assigned to a study. \t
- Assist clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned trials. \t
- Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required. \t
- Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection. \t
- Finalize and review clinical trial protocols, investigator brochures, and clinical study reports as the last review. \t
- Assist with interdepartmental project teams as a central point of contact in the creation of contracts and submit contracts for health care professionals through universities and clinical sites in and/or outside the United States. \t
- Follow the contract through lifecycle with potential amendments. \t
- Adhere to guidelines of investigator and consultant payments within the Fair Market Value ranges per activity. \t
- Create the budget and set up Purchase Order and/or Check Requisition for the payment to clinical research sites and/or third parties as needed. \t
- Interact with internal and external personnel involved in clinical research, including investigative site personnel, as appropriate. \t
- Support the successful execution of assigned studies in conformance with global regulations and internal policies and procedures.
Skills and Requirements:
- BA/BS or higher from an accredited institution and 1-2 years' Clinical Study Assistant, or 3+ years' related clinical research experience. \t
- Strong organizational skills and attention to detail \t
- Proficient in Microsoft Office. \t
- Ability to work with minimal supervision in a Team environment. \t
- The ability to understand written work instructions and follow the requirements. \t
- Fluent in English both verbally as well as with reading and writing skills. \t
- Good communication via written, verbal and listening skills. \t
- Ability to report to corporate offices for routine, daily work.
Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
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