Asclepius Solutions, Inc.

Clinical Research Associate (CRA)

Job Description:

Responsible for monitoring of single-site and multi-site clinical research trials. Assures adherence to international Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR). Assures compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements.

Responsibilities:

• Primary responsibility is site coordination, management and performance of in-house and on-site monitoring (all types of visits such as initiation, monitoring, close out, audit, etc) activities for single and/or multi-institutional studies in accordance with applicable SOPs, ICH, GCP and international/national regulatory requirements.
• Monitor progress of clinical trials and independently develop progress reports for the Investigator (e.g., patient accrual, audit reports and findings, data transmission and data reporting activities, etc).
• Perform quality control and quality assurance (QA/QC) of research data submitted to outside monitoring agencies on multiple National Cancer Institute (NCI) protocols.
• Provide quality control and quality assurance of data recorded on multiple NCI intramural studies, including PI-held IND studies.
• Provide mentoring and project specific training to the staff (e.g., CRAs, QA/QC Specialists, Data Managers, etc).
• Perform administrative duties including attendance of clinical monitoring staff meetings, project team meetings, clinical training sessions etc., as required.
• Maintain awareness of all developments in the field of clinical research by reading related literature, attending professional seminars, etc.
• Performs other tasks as assigned by Project Manager and Team Lead.

Qualifications:

• BS in Health or Biological Sciences and minimum 3 years of CRA experience
• Advanced degree such as MD, RN or MS desirable
• Knowledge of procedures for monitoring clinical trials, GCP/ICH guidelines and medical terminology is mandatory

• Knowledge of clinical research and operations - must have a thorough understanding of clinical research protocols, data collection requirements, and methodologies
• Hands on experience required on Clinical Data Management (CDMS), Electronic Data Capture (EDC), and Electronic Medical Records (EMR) systems
• Must be able to work independently and with others

Preferred Additional Skills:

• Excellent organizational, communication, and computer skills
• Health or clinical certification (e.g. CCRP) highly desirable
• Knowledge of PI-Held IND Studies preferred
• Experience with academic institutions preferred

Employee Benefits

• Paid Time Off
• Holidays
  
• Medical Insurance
• Dental Insurance
• Vision Insurance
• Health Savings Account
• Life Insurance
• Long Term Disability Insurance
• 401(k) with company matching
• Flexible/Compressed Work Schedule