CenterWatch

Keep the discussion going--join our JobWatch Group on LinkedIn!

Sign In
 [New User? Sign Up]
Mobile Version

Home-based Regional Clinical Research Associate

Kelly Services


Location:
Deerfield, IL
Date:
04/18/2018
2018-04-182018-05-17
Job Code:
US33MXGR_BH1430799
Categories:
  • Healthcare
  • Monitoring
Kelly Services
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Job Title Home-based Regional Clinical Research Associate

Jobid US33MXGR_BH1430799

Location: Deerfield, IL, 60015, USA

Description Kelly Services has an immediate opening for a home-based Regional Clinical Research Associate to monitor sites in OH, MI, IA, WA, TX & CA. Candidates must reside within 20-25 miles of a major airport in one of these states. The primary responsibility of the Clinical Research Associate (CRA) is to support the Clinical Project Manager with the day-to-day activities pertaining to clinical trials conducted for new product license applications, line extensions for existing products, and post marketing commitments.

Responsibilities:


+ Monitoring clinical trials to ensure high quality and valid study data that supports regulatory applications and approval of new-marketed projects and indications.
+ Assist in training clinical investigative sites to ensure adherence to the protocol, GCP, and all applicable regulations and related study document.
+ Oversight and interaction with clinical research sites to include: regulatory document collection, enrollment tracking, review of patient charts and clinical research data for accuracy and completeness.
+ Assist with the set-up and management of study sites.
+ Review essential documents from study sites for accuracy and completion.
+ Primary contact for coordination of protocol questions from study sites: Answering administrative protocol questions according to level of experience.
+ Assist the reporting of adverse experiences per SOP and protocol requirements.
+ Monitor sites product supply needs and oversee site shipments in alignment with the Clinical Supply group.
+ On-site data monitoring of EDC data and source documents Generate site visit reports and escalation of issues, as needed.
+ Manage clinical aspects of database lock by participating in data listing review and coordinating DCF resolution with sites.
+ Draft periodic study newsletters.
Qualifications


+ Familiar with US Federal Food and Drug Administration, ICH/GCP/ISO, local regulations, as applicable to a clinical study.
+ Able to understand the disease under study and the aim of the therapy.
+ Should be able to understand the relevant sections of the study protocol.
+ Demonstrates proficiency in computer operations in Windows.
+ Environment and is able to utilize available software for documents, spreadsheets and email.
+ Demonstrated experience with CTMS, EDC, monitoring EMR and RAVE is required; experience with CRRT is highly preferred.
+ Must be able to handle multiple projects at a time and have strong attention to detail while keeping the global picture.
+ Excellent verbal and written communication skills required.
+ Able to produce accurate and well-presented documents.
+ Interpersonal and organizational skills are a must.
+ Solution orientated mindset.
+ Must be flexible in order to accommodate changes in team and project needs.
Education/Experience


+ BA/BS in scientific equivalent and /or Nursing with CRA experience
+ 3-5 years site monitoring in pharmaceutical, biotechnology or medical device company including CRO.
+ CRRT experience a plus.
+ Previous experience with CTMS and EDC is necessary. RAVE experience is a plus.
+ Experience monitoring with electronic medical records.
+ Domestic Travel 30-50% is required.
+ Familiar with FDA, ICH/GCP/ISO, local regulations If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:

Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
*perks to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



Powered ByLogo