Calsoft Labs
Location
King of Prussia, PA | United States
Job description
The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product. Responsibilities
Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol. Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research. Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. Skills:* CRA, Monitoring, Medical Device, CRO, ICH, GCP, FDA, Clinical Research, Clinical Trials Top Skills Details:* CRA,Monitoring,Medical Device Additional Skills & Qualifications:* Bachelor of Science Degree 4-5 Years + experience with a Sponsor or CRO Site Monitoring Experience Work experience at more than 1 company Experience with set-up monitoring plan, conducted site monitoring, and conducted site close-out. Medical Device preferred, Pharma OK, CRO OK Experience Level:* - Entry LevelJob tags
Salary
