Clinical Research Coordinator
At Clinical Research Advantage, Inc. it's our people that set us apart. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. This is an excellent opportunity for an individual experienced in clinical trials.
Clinical Research Advantage is a leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. CRA has completed over 1,800 clinical trials in its 20 years. CRA is comprised of community based Investigators plus an experienced staff of Clinical Research Coordinators. CRA currently operates from its 33 site network across seven states. The key to our success has been the development of research departments within established medical practices. Our research staff is positioned in the clinic, which affords CRA rapid recruitment of reliable, qualified subjects into clinical trials. Our expertise continues throughout the trial, providing full execution of the protocol with complete and accurate data. CRA enjoys a strong reputation for quality and is focused on patient care.
We are currently looking for an Clinical Research Coordinator for our site in Fremont, Nebraska. The Clinical Research Coordinator (CRC), as delegated by the principal investigator, executes and coordinates daily clinical research activities according to CRA’s SOPs, GCP and FDA/ICH guidelines. Ensures IRB approved protocols are implemented and followed. Executes informed consent process and monitors patient status and safety; collects and organizes research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; educates patients and their families about treatments and possible side effects. The Clinical Research Coordinator must also be able to perform clinical tasks (i.e. phlebotomy, EKGs, vital signs, etc.). CRCs typically perform tasks such as:
- Site preparation
- Obtaining informed consent
- Patient screening and recruitment
- Patient enrollment
- Conducting study visits
- Maintaining and dispensing study product and supplies
- Completing and ensuring the quality of case report forms
- Maintaining source documents
- Ensuring site quality
- Responding to queries in a timely manner
Educational Qualifications : Bachelor's degree and a minimum of 1 year of related experience OR 2 or more years of study coordination experience, or an equivalent combination of education and experience.
- Phlebotomy and EKG experience preferred;
- Familiarity with GCP and FDA/ICH regulations;
- Microsoft Office skills; and
- Must have excellent written, verbal and interpersonal skills, strong organization skills, and a strong attention to detail.
Certification from either ACRP (CCRC) or SoCRA (CCRP) will be required once all qualifications have been met. HAZMAT certification;
Join Clinical Research Advantage as we expand and become an important part of a well-respected and growing company that believes the details of your career are every bit as critical as the work you do.
You'll enjoy a regular schedule (Monday – Friday), competitive compensation (with bonus potential) and an exceptional benefits package that includes: Medical, Dental and Vision Insurance, Life and AD&D Insurance, disability, 401K Plan with matching contributions, a competitive program of time off and more.
To learn more about our company visit us as www.crastudies.com
Clinical Research Advantage - 5 months ago