Description
The Clinical Research Associate will be responsible for planning, preparing, executing and closing out in-patient Acute Ischemic Stroke Clinical Trials. The primary focus is AIS, however, this role may also support Hemorrhagic Clinical Trial activities.Responsibilities may include:
- Track Screening & Enrollment and identify issues
- Independently confirm that site regulatory documents match TMF
- Address non compliance issues at investigative site and develop CAPA if necessary
- Reviews Project Plan, disseminates project information, assembles and tracks metrics data
- Monitor Case Report Forms against medical records on a simple trial
- Conduct device accountability at investigational site independently
- Train new study coordinators on ICH/GCP guidelines
- Identifies adverse events during monitoring and ensures sites complete appropriate reporting
- Assists in reviewing medical publications
- Assembles portions of clinical protocols in development under guidance of Sr. CRA and Project Manager
- Utilize clinical knowledge to improve clinical compliance on internal processes and at external clinical sites
Position Requirements:
- 2+ years of direct related experience in Neurovascular, endovascular or Cardiovascular clinical trials
- Bachelors Degree in Science or Healthcare Related Field; Ability to travel up to 50% during peek periods
To find out more about Real please visit www.realstaffing.com